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Trial record 52 of 380 for:    FERRIC CATION

A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01920854
Recruitment Status : Completed
First Posted : August 12, 2013
Results First Posted : December 19, 2014
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Kidney Failure, Chronic Therapy; Hemodialysis
Interventions Drug: soluble ferric pyrophosphate
Drug: Placebo
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohorts 1 - 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5). A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Period Title: Overall Study
Started 12 6 6 6 6 6 6
Completed 11 6 6 6 5 6 5
Not Completed 1 0 0 0 1 0 1
Reason Not Completed
Withdrawal by Subject             1             0             0             0             1             0             1
Arm/Group Title Cohorts 1 - 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP Total
Hide Arm/Group Description A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5). A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours. Total of all reporting groups
Overall Number of Baseline Participants 12 6 6 6 6 6 6 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
48
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
Female
4
  33.3%
2
  33.3%
4
  66.7%
3
  50.0%
4
  66.7%
5
  83.3%
1
  16.7%
23
  47.9%
Male
8
  66.7%
4
  66.7%
2
  33.3%
3
  50.0%
2
  33.3%
1
  16.7%
5
  83.3%
25
  52.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
  16.7%
0
   0.0%
2
   4.2%
Not Hispanic or Latino
12
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
5
  83.3%
5
  83.3%
6
 100.0%
46
  95.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  25.0%
1
  16.7%
1
  16.7%
0
   0.0%
1
  16.7%
1
  16.7%
1
  16.7%
8
  16.7%
White
9
  75.0%
5
  83.3%
5
  83.3%
6
 100.0%
4
  66.7%
5
  83.3%
5
  83.3%
39
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
1
   2.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
12 6 6 6 6 6 6 48
1.Primary Outcome
Title Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
Hide Description

Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 1 - 3, 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL
t = 0 hrs 18.87125  (19.08355) 14.625  (13.54503) 20.13333  (9.256061) 14.806  (10.09701) 31.73333  (17.07579)
t = 0.5 hrs 19.25243  (12.97435) 22.075  (15.44849) 33.21167  (16.22149) 41.53333  (17.55844) 58.65  (21.0115)
t = 1 hr 23.555  (16.79989) 40.34  (14.2365) 47.45  (19.26954) 67.24  (29.08003) 95.21667  (18.84658)
t = 2 hrs 32.54286  (32.58808) 73.15  (62.48) 88.28333  (22.29039) 119.34  (46.55242) 150.3333  (22.43806)
t = 3 hrs 41.3125  (31.5142) 77.64  (25.54981) 112.7333  (29.95721) 173.4  (17.38678) 210  (26.54807)
t = 4 hrs 43.75  (39.09914) 82.76  (10.01489) 143.4167  (33.93585) 206  (37.76242) 241.5  (25.6963)
t = 4.5 hrs 46.99  (33.692) 94.38  (12.827) 150.8  (39.0858) 196.25  (46.29885) 258.3333  (32.20973)
t = 5 hrs 50.74714  (39.71965) 88.88  (30.95007) 135.26  (40.90584) 207.5  (41.23469) 238.1667  (27.28675)
t = 6 hrs 46.3375  (32.43362) 86.1  (23.73584) 118.6  (40.09489) 179.0833  (40.56158) 214.5  (31.14322)
t = 7.5 hrs 26.27143  (25.89638) 49.33333  (35.15774) 81.35  (18.15717) 131.45  (31.91825) 170.8333  (27.63633)
t = 8 hrs 20.1875  (19.10194) 40.91667  (32.76452) 60.02833  (38.13224) 118.25  (38.3246) 148  (28.2772)
t = 9 hrs 7.852857  (25.84383) 30.75  (51.07636) 44.21667  (20.25452) 79.96  (32.5411) 122.6833  (21.64813)
t = 10 hrs -0.1875  (18.48079) -2.76  (32.67052) 24.02833  (19.2209) 64.68333  (37.53566) 81.01667  (25.26099)
t = 12 hrs -11.8538  (20.68082) -30.9866  (23.72293) -5.89333  (17.29701) 23.21667  (42.48879) 32.91667  (22.9566)
t = 12.5 hrs -11.7838  (24.1043) -31.966  (22.61386) -10.3888  (20.13357) 15.26667  (27.3353) 28.13333  (32.85319)
t = 14 hrs -14.525  (23.13773) -38.3883  (18.17201) -22.5  (13.67333) 0.895  (27.98098) -6.56617  (24.95741)
t = 16 hrs -23.0004  (26.67792) -39.5  (15.30849) -19.905  (17.7931) -12.35  (31.50294) -23.5  (28.53482)
t = 20 hrs -16.7163  (29.37565) -43.8  (13.72461) -23.655  (21.6553) -11.0612  (15.55449) -35.55  (22.41006)
t = 24 hrs 10.34714  (16.82299) 11.7  (33.80067) 6.542  (13.5174) 2.05  (15.61893) -11.655  (20.10851)
t = 36 hrs -4.24286  (15.34727) -43.7666  (28.14838) -9.72167  (20.08234) -12.2612  (17.42613) -27.3  (15.28005)
t = 48 hrs 21.73286  (19.95647) 11.47783  (44.51915) 21.82333  (19.21886) 41.4  (50.85712) 48.46  (18.48764)
2.Primary Outcome
Title Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
Hide Description

Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 4 and 5 Placebo Cohort 4 SFP Cohort 5 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Overall Number of Participants Analyzed 4 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL
t = 0 hrs 22.575  (8.144272) 15.55  (11.59451) 7.888333  (33.94121)
t = 0.5 hrs 21.7  (13.11602) 26.25  (13.70631) 29.97167  (33.57264)
t = 1 hr 23  (11.37629) 49.46667  (12.52576) 68.23333  (44.6479)
t = 2 hrs 24.9325  (17.2084) 77.62  (17.82826) 107.6333  (43.33413)
t = 4 hrs 41.16667  (32.85869) 140.2  (19.84187) 197.6667  (46.28031)
t = 6 hrs 42.975  (36.03807) 168.8  (35.75891) 232  (48.90808)
t = 9 hrs 17.6  (41.26835) 167.2  (42.3757) 228.8333  (44.96851)
t = 12 hrs 2.175  (29.20575) 176  (43.28972) 214.5  (49.31835)
t = 12.5 hrs -5.53333  (28.14255) 141.3833  (49.73572) 208.1667  (51.0232)
t = 14 hrs -2.9  (24.60732) 116.7  (47.4452) 161.9667  (46.50513)
t = 16 hrs -19.1667  (15.64811) 38.18  (30.55899) 92.43833  (56.28477)
t = 18 hrs -12.3  (13.66711) 25.84  (37.53582) 47.605  (37.80162)
t = 20 hrs -5.2889  (7.137707) -6.06667  (31.71553) -3.09  (29.31886)
t = 24 hrs 21.62233  (19.48729) -10.2333  (35.97225) -20.0617  (26.62087)
t = 30 hrs 31.485  (48.38732) -30.225  (27.25856) -25.6333  (29.99492)
t = 36 hrs -0.52333  (21.42192) -23.15  (40.39885) -34.6333  (41.33162)
t = 48 hrs 34.03333  (13.70632) 36.02  (26.44139) 19.95  (39.70616)
3.Primary Outcome
Title Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
Hide Description

Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 1 - 3, 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL
t = 0 hrs 15.81588  (15.29313) 27.45  (10.6442) 24.76667  (12.58438) 18.03333  (13.6192) 34.47833  (22.29513)
t = 0.5 hrs 16.12875  (16.956) 36.86667  (8.992145) 46.41667  (11.35067) 48.3  (16.06275) 62.93333  (20.16231)
t = 1 hr 24.04125  (23.55888) 51.73333  (10.18797) 70.8  (14.34489) 81.31667  (21.66614) 102.8  (22.60044)
t = 2 hrs 26.3875  (17.3591) 69.25  (11.37853) 112.55  (17.88449) 142.9  (27.52417) 166.6667  (22.00606)
t = 3 hrs 36.7375  (24.39203) 96.06667  (17.22355) 1148.3333  (26.3717) 194.3333  (39.70222) 223.6667  (21.58394)
t = 4 hrs 42.5375  (27.70637) 111.4167  (21.85437) 179.1667  (35.79618) 229.8333  (58.21483) 247.8333  (28.47045)
t = 4.5 hrs 46.3125  (26.86966) 113  (10.55936) 183.5  (37.35639) 230.5  (54.47844) 259.1667  (36.66833)
t = 5 hrs 47.8375  (31.67153) 105.95  (21.48299) 171.3333  (34.4248) 240.6667  (42.41541) 241.8333  (21.80291)
t = 6 hrs 39.7125  (23.02839) 95.5  (21.20547) 149  (31.89357) 188.95  (53.37429) 222.8333  (26.60388)
t = 7.5 hrs 21.84125  (16.90949) 62.58333  (27.26891) 95.25  (18.04658) 158.2667  (63.67312) 175.8333  (27.83822)
t = 8 hrs 16.7375  (14.66799) 50.58333  (27.42418) 84.1  (23.7459) 125.1  (50.25754) 154.1667  (30.0494)
t = 9 hrs 3.245  (9.291451) 30.23833  (30.05141) 52.21667  (17.32494) 104.1883  (51.15559) 125.35  (23.78098)
t = 10 hrs -5.4175  (8.513109) 4.028333  (21.84233) 25.38333  (18.08142) 67.95  (42.27547) 87.16667  (31.49366)
t = 12 hrs -18.8714  (17.95569) -22.0445  (14.59163) -7.33333  (19.53363) 28.65  (22.83486) 32.745  (29.99864)
t = 12.5 hrs -22.8429  (22.18268) -27.4617  (12.8595) -10.2667  (22.21894) 15.68333  (19.74056) 24.82833  (38.29261)
t = 14 hrs -25.4481  (27.93334) -33.9617  (16.56204) -14.85  (28.31902) 3.167167  (13.43837) -6.195  (29.40307)
t = 16 hrs -29.4667  (32.86135) -35.8  (16.87637) -23.4283  (26.12766) -12.0333  (33.63212) -28.2167  (30.50996)
t = 20 hrs -20.7163  (31.3054) -27.7  (30.14558) -24.7233  (22.46531) -18.1717  (16.19425) -40.4883  (27.31494)
t = 24 hrs 14.05  (14.51925) 21.505  (37.16592) 0.116667  (16.23887) 7.605  (22.55452) -16.455  (21.98194)
t = 36 hrs -15.6767  (31.81849) -39.8117  (31.90823) -16.6567  (16.39093) -11.74  (14.89775) -37.3  (14.24949)
t = 48 hrs 25.4875  (16.85459) 26.68333  (51.62024) 35.36667  (12.16251) 40.945  (32.03071) 42.94  (12.77861)
4.Primary Outcome
Title Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
Hide Description

Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 4 and 5 Placebo Cohort 4 SFP Cohort 5 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Overall Number of Participants Analyzed 4 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL
t = 0 hrs 26.675  (10.10095) 17.13333  (13.10836) 22.31167  (25.13075)
t = 0.5 hrs 24.6  (12.80989) 32.36667  (14.44322) 46.76667  (25.7235)
t = 1 hr 31.35  (14.11772) 56.01667  (12.43309) 80.48333  (26.35234)
t = 2 hrs 35.75  (16.21532) 93.36667  (16.01058) 136.3333  (27.94041)
t = 4 hrs 50.9  (26.83927) 152  (14.02854) 222.5  (41.28801)
t = 6 hrs 55  (38.45179) 186.8  (27.12379) 255.5  (51.20059)
t = 9 hrs 24.285  (43.9688) 181.3333  (34.92659) 254.5  (60.24201)
t = 12 hrs -0.975  (28.42761) 178.5  (47.26415) 236.8333  (62.58887)
t = 12.5 hrs -3.86667  (28.73436) 157.6667  (47.00496) 237.8333  (68.42051)
t = 14 hrs -7.03333  (19.74369) 117.3333  (45.18808) 180.65  (69.86598)
t = 16 hrs -12.1867  (10.43401) 57.75  (41.30815) 114.3117  (73.84014)
t = 18 hrs -11.52  (11.5913) 17.705  (33.84819) 58.51667  (63.66288)
t = 20 hrs -0.67667  (20.99592) -8.81667  (25.93025) 12.61167  (53.50657)
t = 24 hrs 30.39  (23.14673) -12.0567  (25.6596) -9.53833  (41.94388)
t = 30 hrs 26.44667  (41.6933) -18.8283  (30.65685) -22.9778  (23.78139)
t = 36 hrs -5.4  (27.97803) -28.1672  (32.82391) -28.35  (35.19118)
t = 48 hrs 40.46667  (15.25036) 41.026  (34.08901) 30.78333  (48.96756)
5.Primary Outcome
Title Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
Hide Description

Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 1 - 3, 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL
t = 0 hrs 350  (44.2) 318  (28.3) 334  (23.8) 352  (53.1) 352  (35.9)
t = 0.5 hrs 344  (41.6) 312  (27.3) 328  (24.9) 344  (54.5) 348  (37.5)
t = 1 hr 345  (51.6) 318  (29.5) 334  (22.8) 348  (53.9) 352  (35.7)
t = 2 hrs 346  (45.6) 312  (31.9) 330  (29.9) 347  (56.6) 342  (36.6)
t = 3 hrs 348  (43) 313  (28.5) 329  (26.6) 344  (52.8) 342  (38.4)
t = 4 hrs 348  (41.1) 312  (29.4) 328  (23.4) 340  (51.2) 341  (37.4)
t = 4.5 hrs 359  (45.1) 324  (35.7) 339  (22.3) 337  (46.9) 352  (35.5)
t = 5 hrs 358  (43.6) 318  (27.6) 338  (24.4) 352  (42.6) 350  (37.9)
t = 6 hrs 356  (44) 315  (26) 338  (24.8) 356  (53.6) 348  (37.8)
t = 7.5 hrs 347  (56.1) 318  (27) 332  (29.3) 355  (52.8) 348  (36.1)
t = 8 hrs 359  (38.6) 319  (27.7) 339  (25.2) 356  (54.4) 348  (34.6)
t = 9 hrs 348  (51.6) 324  (27) 338  (29.6) 351  (47.2) 349  (34.9)
t = 10 hrs 352  (41.4) 317  (26.7) 338  (28.8) 355  (52.4) 347  (34.6)
t = 12 hrs 351  (43) 319  (26.3) 333  (29.5) 360  (53.5) 344  (33.5)
t = 12.5 hrs 344  (52.7) 316  (30.7) 336  (23.5) 351  (46.3) 350  (25.8)
t = 14 hrs 340  (61.9) 316  (31.1) 335  (31.8) 356  (48.4) 344  (39.6)
t = 16 hrs 341  (41.1) 304  (46.8) 327  (27.1) 353  (27.5) 344  (36.9)
t = 20 hrs 342  (48.8) 301  (40.8) 326  (23.4) 350  (52.3) 338  (32.4)
t = 24 hrs 355  (43.4) 314  (30.8) 346  (22.6) 362  (50) 353  (35)
t = 36 hrs 362  (39.4) 318  (24.8) 344  (24.6) 364  (50.4) 357  (38.4)
t = 48 hrs 364  (43.2) 320  (30.5) 346  (19.3) 370  (54.4) 352  (36.3)
6.Primary Outcome
Title Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
Hide Description

Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 4 and 5 Placebo Cohort 4 SFP Cohort 5 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Overall Number of Participants Analyzed 4 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL
t = 0 hrs 345  (22.3) 346  (49.8) 340  (41.1)
t = 0.5 hrs 332  (18.8) 328  (41.8) 328  (36.6)
t = 1 hr 340  (15.9) 338  (42) 336  (40.4)
t = 2 hrs 337  (17.6) 336  (43.8) 335  (36.6)
t = 4 hrs 338  (19.1) 336  (42.4) 335  (43.7)
t = 6 hrs 334  (22.9) 338  (40.8) 317  (41.3)
t = 9 hrs 330  (19.5) 324  (37.8) 318  (37.7)
t = 12 hrs 334  (33.3) 319  (40.2) 308  (35.1)
t = 12.5 hrs 333  (20.8) 325  (37.1) 323  (35.1)
t = 14 hrs 339  (19.3) 328  (41.7) 325  (31.8)
t = 16 hrs 338  (21.4) 340  (37.8) 325  (32.2)
t = 18 hrs 342  (13.9) 337  (40.2) 330  (34.3)
t = 20 hrs 337  (18.9) 329  (40.4) 325  (39)
t = 24 hrs 346  (31.2) 344  (43.3) 342  (39.4)
t = 30 hrs 344  (28.3) 339  (42.2) 350  (35.1)
t = 36 hrs 346  (33.7) 344  (46.4) 345  (35.4)
t = 48 hrs 352  (20.8) 337  (42.6) 343  (38.8)
7.Primary Outcome
Title Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
Hide Description

Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 1 - 3, 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL
t = 0 hrs 2.98  (7.07) -5.44  (5.35) -4.66  (6.42) -4.74  (7.01) -1.42  (5.22)
t = 0.5 hrs 5.93  (11.5) -7.54  (8.74) -13.2  (9.7) -7.65  (21.8) -4.92  (6.33)
t = 1 hr -0.554  (11.6) -2.51  (10.1) -23.4  (9) -13.9  (35.8) -7.54  (3.74)
t = 2 hrs 5.07  (19.6) 12  (53.5) -24.5  (11.9) -26.9  (29.5) -13.8  (6.34)
t = 3 hrs 4.5  (15.9) -11.9  (10.3) -35.6  (9.85) -23.7  (30.1) -9.69  (6.81)
t = 4 hrs 1.17  (12.6) -13.2  (19.8) -35.7  (16.4) -24.3  (23.5) -6.96  (5.75)
t = 4.5 hrs 0.0952  (13.2) -9.79  (26.5) -32.9  (16.5) -27  (22) 0.744  (13.3)
t = 5 hrs 1.01  (15.4) -10.7  (11.5) -32.7  (15) -34  (19.7) -2.92  (15.3)
t = 6 hrs 6.55  (20.1) -10.1  (11.3) -30.4  (13.4) -11  (28) -7.16  (13.5)
t = 7.5 hrs 3.3  (14.5) -6.01  (10.1) -13.9  (13.6) -27.4  (44.4) -5.09  (16.5)
t = 8 hrs 3.37  (10.6) -2.43  (9.75) -24  (20.1) -7.72  (25.1) -5.74  (11.1)
t = 9 hrs 6.31  (20.8) 7.69  (26.8) -8.02  (7.3) -27  (36) -2.44  (16.2)
t = 10 hrs 5.16  (12.8) 1.51  (6.03) -1.37  (4.46) -4.22  (31.2) -5.56  (11.3)
t = 12 hrs 9.52  (14.9) -3.11  (9.14) 1.43  (5.26) -6.32  (42.9) -0.472  (16.2)
t = 12.5 hrs 12.7  (21.2) 1.17  (9.66) -0.139  (6.84) -1.3  (30.4) 2.66  (11.1)
t = 14 hrs 11  (12.8) 2.82  (12.6) -3.44  (17.9) -3.15  (28.3) -1.01  (6.73)
t = 16 hrs 6.32  (11.1) 4.85  (12.7) 3.51  (10.3) -1.2  (32.5) 4.08  (10.7)
t = 20 hrs 3.92  (9.3) 0.353  (22.2) 1.06  (6.27) 6.22  (25.3) 4.29  (6.91)
t = 24 hrs -3.37  (4.87) -6.39  (12.5) 5.47  (5.98) -6.43  (31.1) 4.16  (9.23)
t = 36 hrs 2.97  (10) 1.51  (15.2) 6.93  (5.2) -1.4  (23.6) 9.36  (8.63)
t = 48 hrs -6.73  (14.6) -7.56  (11.7) -13.6  (19.7) -1.65  (24.3) 4.74  (14.3)
8.Primary Outcome
Title Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
Hide Description

Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 4 and 5 Placebo Cohort 4 SFP Cohort 5 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Overall Number of Participants Analyzed 4 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL
t = 0 hrs -4.08  (2.22) -1.58  (2.45) -13.9  (25.8)
t = 0.5 hrs -7.44  (8.71) -5.95  (7.54) -14.8  (26.7)
t = 1 hr -6.63  (4.35) -5.93  (8.93) -9.99  (38.2)
t = 2 hrs -10.4  (7.52) -12.9  (23.4) -20.7  (28.1)
t = 4 hrs -6.57  (4.26) -10.1  (8.65) -17.6  (28.7)
t = 6 hrs -10.8  (12.3) -15.8  (16.4) -18.1  (28.6)
t = 9 hrs -6.53  (13.2) -10.1  (18.3) -19.8  (28.2)
t = 12 hrs 3.17  (2.29) -11.7  (12.8) -18.4  (22.4)
t = 12.5 hrs -1.63  (1.54) -16.3  (15.5) -20.2  (28.3)
t = 14 hrs 0.0167  (1.39) -3.38  (7.01) -14.2  (33.5)
t = 16 hrs -6.97  (13.6) -6.93  (9.07) -17.9  (29.5)
t = 18 hrs -0.767  (9.7) 1.81  (8.29) -8.14  (28)
t = 20 hrs -4.6  (14.9) 2.75  (8.15) -14.4  (31)
t = 24 hrs -8.63  (8.31) 1.83  (16.3) -10.8  (27.5)
t = 30 hrs -3.68  (3.09) 1.22  (9.34) -2.87  (35.6)
t = 36 hrs 4.9  (9.01) 5.32  (20.5) -6.44  (29.2)
t = 48 hrs -4.63  (1.7) -4.03  (22.1) -8.46  (36.1)
9.Primary Outcome
Title Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
Hide Description

Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 1 - 3, 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL
t = 0 hrs -15.7  (16.3) -27  (9.55) -22.9  (10.7) -17.9  (13.9) -37.4  (24)
t = 0.5 hrs -22.4  (19.4) -41.5  (7.97) -50.2  (10.7) -56.8  (17.3) -70.7  (23.8)
t = 1 hr -29.1  (34.7) -51.1  (9.91) -68.7  (10.6) -85.9  (19.2) -106  (22.6)
t = 2 hrs -30.3  (24.2) -74.1  (10.9) -115  (22.9) -148  (25.9) -179  (25.1)
t = 3 hrs -38.9  (26.7) -100  (21.4) -152  (26.2) -201  (39.2) -229  (30.6)
t = 4 hrs -44.8  (31.2) -117  (22.6) -182  (36.1) -242  (58.8) -246  (29.4)
t = 4.5 hrs -37.9  (33.2) -103  (10.6) -175  (34.5) -222  (59.4) -243  (30.8)
t = 5 hrs -39.9  (37.8) -105  (25.5) -166  (35.9) -237  (60.6) -239  (30.5)
t = 6 hrs -34.5  (29.7) -97.3  (25.8) -143  (31.4) -185  (50.9) -228  (33.5)
t = 7.5 hrs -25.1  (35.4) -61.8  (28.7) -95.3  (26.9) -156  (68.9) -183  (32.3)
t = 8 hrs -8.54  (15.5) -48.9  (26.6) -77.4  (26.2) -121  (52.5) -161  (34.8)
t = 9 hrs -5.54  (23.6) -23.6  (22.9) -46.5  (25.5) -106  (56.4) -132  (29.7)
t = 10 hrs 7  (12) -3.71  (18.1) -20  (23.6) -65.7  (50.1) -95.5  (34.9)
t = 12 hrs 19.4  (10.5) 24.4  (13.7) 8.56  (26.4) -21.5  (33.7) -43.7  (32)
t = 12.5 hrs 17.1  (10.6) 26  (13.6) 14  (32) -16.7  (33.7) -30.6  (34.4)
t = 14 hrs 16  (8.71) 32.8  (11.5) 17.7  (37.1) 0.667  (20) -5.4  (34.1)
t = 16 hrs 21  (24.1) 22.5  (21.5) 18.5  (30.1) 10.8  (10.6) 16.5  (33.1)
t = 20 hrs 11.8  (19.4) 11.9  (28.5) 19  (25.4) 15.3  (15.5) 23.1  (26.3)
t = 24 hrs -9.1  (13.8) -24.7  (32.2) 13.8  (22.8) 1.57  (23) 14  (16.5)
t = 36 hrs 28.1  (28.6) 41.1  (30.1) 28.6  (19.5) 23.1  (15.1) 38.7  (21.1)
t = 48 hrs -12.2  (25.3) -23.4  (46.3) -21.1  (16) -23.8  (38.3) -44.4  (18.4)
10.Primary Outcome
Title Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
Hide Description

Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 4 and 5 Placebo Cohort 4 SFP Cohort 5 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Overall Number of Participants Analyzed 4 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL
t = 0 hrs -19.7  (8.82) -12.4  (17.6) -19.4  (29.5)
t = 0.5 hrs -30.4  (11.6) -46.5  (9.79) -56.3  (29.7)
t = 1 hr -29.7  (16.2) -59.8  (8.85) -81.3  (29.2)
t = 2 hrs -37.1  (19.2) -99.2  (14) -138  (32.9)
t = 4 hrs -51.2  (25.8) -158  (21.6) -216  (27.9)
t = 6 hrs -58.7  (41.6) -189  (38.5) -247  (37.5)
t = 9 hrs -32.4  (46.3) -199  (41.6) -246  (44.2)
t = 12 hrs -3.59  (30.8) -201  (51.9) -241  (51.8)
t = 12.5 hrs -1.21  (29.8) -174  (66.1) -236  (60.7)
t = 14 hrs 8.29  (17.2) -131  (52.9) -193  (76.1)
t = 16 hrs 11.8  (11.2) -59.7  (58.2) -126  (76.4)
t = 18 hrs 15.4  (20.3) -22.3  (44.6) -65.7  (65.6)
t = 20 hrs -0.0778  (30.5) -3.63  (33.6) -24.7  (52.8)
t = 24 hrs -22.8  (33.3) 14.6  (24.6) 14.3  (49.4)
t = 30 hrs -20.9  (53.3) 15.9  (35.5) 35.8  (28.1)
t = 36 hrs 13.7  (39.4) 30.1  (37.7) 36.6  (34.6)
t = 48 hrs -26.2  (25.3) -35.8  (36.2) -24.5  (54.8)
11.Primary Outcome
Title Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6
Hide Description The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)
Time Frame Baseline (1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 1 - 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mg/dL
306.583  (35.1606) 283.500  (29.9850) 315.500  (40.7909) 348.333  (59.9956) 303.833  (47.2966) 314.571  (52.6841) 304.167  (53.2143)
12.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
Hide Description

Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 1 - 3, 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: percentage of saturation
t = 0 hrs 25.70875  (18.521548) 41.85  (12.577559) 27.466667  (13.091626) 26.383333  (10.936986) 39.066667  (10.129495)
t = 0.5 hrs 26.375  (19.6707) 45.583333  (12.795533) 34.5  (12.94805) 35.716667  (11.168781) 47.85  (10.774368)
t = 1 hr 29.4125  (23.073141) 49.533333  (13.224019) 41.266667  (14.069921) 45.016667  (11.995902) 58.583333  (11.177373)
t = 2 hrs 29.5625  (21.098337) 56.15  (13.052624) 54.75  (15.895377) 63.05  (13.895719) 79.45  (14.417039)
t = 3 hrs 32.1875  (21.176904) 64.666667  (16.043898) 65.866667  (17.335128) 78.15  (14.831015) 96.066667  (12.873176)
t = 4 hrs 33.9625  (22.445867) 69.883333  (16.560002) 75.233333  (19.819048) 88.8  (11.348128) 102.83333  (7.5210815)
t = 4.5 hrs 34.1  (21.703917) 64.6  (12.73185) 74.25  (20.471614) 88.24  (13.994034) 102.93333  (10.715721)
t = 5 hrs 34.825  (24.362251) 66.8  (16.702934) 70.983333  (19.212227) 89.516667  (12.587679) 98.716667  (9.4961922)
t = 6 hrs 32.75  (21.835816) 64  (16.355427) 64.116667  (18.901896) 74.133333  (19.031938) 93.966667  (11.727688)
t = 7.5 hrs 29.375  (24.115659) 53.083333  (16.412973) 49.316667  (16.104089) 65.2  (18.721218) 80.483333  (13.813532)
t = 8 hrs 25.38625  (17.277825) 49.183333  (15.874182) 44.9  (17.190579) 56.15  (19.282298) 74.316667  (15.067902)
t = 9 hrs 23.18875  (18.870984) 41.866667  (14.993421) 35.533333  (15.038972) 50.483333  (18.139506) 65.816667  (13.489613)
t = 10 hrs 19.4325  (13.439108) 34.466667  (13.005794) 27.416667  (13.433453) 40.133333  (17.189842) 55.366667  (15.617127)
t = 12 hrs 16.518571  (9.4347451) 25.916667  (9.637306) 17.828333  (11.615611) 28.783333  (13.911925) 39.866667  (13.873812)
t = 12.5 hrs 15.968571  (9.7540546) 24.566667  (8.6832406) 16.771667  (11.701778) 25.618333  (12.537496) 36.866667  (14.673196)
t = 14 hrs 15.332857  (7.8527208) 22.483333  (8.5307483) 15.301667  (8.8581091) 21.486667  (10.91862) 28.716667  (13.00514)
t = 16 hrs 13.305714  (3.6857693) 23.366667  (10.372592) 12.835  (6.5323617) 15.85  (4.4440972) 22.2  (12.467879)
t = 20 hrs 14.835  (4.4686303) 25.916667  (10.491981) 12.386667  (4.4342606) 16.025  (7.9655351) 18.633333  (10.414157)
t = 24 hrs 24.4125  (10.022038) 40  (8.7824826) 19  (5.8845561) 22.733333  (8.7016474) 24.483333  (8.0759932)
t = 36 hrs 16.454286  (5.1594536) 19.883333  (5.2162886) 14.198333  (6.6138655) 17.441667  (9.7067696) 18.213333  (5.4371561)
t = 48 hrs 27.55  (15.727683) 40.533333  (14.972864) 29.383333  (11.362291) 31.766667  (17.181928) 41.58  (8.2156558)
13.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
Hide Description

Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 4 and 5 Placebo Cohort 4 SFP Cohort 5 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Overall Number of Participants Analyzed 4 6 6
Mean (Standard Deviation)
Unit of Measure: percentage of saturation
t = 0 hrs 30.95  (3.2583227) 26.5  (10.784062) 32.45  (10.532379)
t = 0.5 hrs 31.55  (4.2930176) 32.6  (11.667219) 41.3  (11.031591)
t = 1 hr 32.875  (4.7422744) 38.633333  (11.449658) 50.283333  (10.526997)
t = 2 hrs 34.525  (5.4267086) 50  (12.552928) 67.266667  (13.599069)
t = 4 hrs 38.95  (7.485319) 67.55  (12.12151) 92.833333  (14.211498)
t = 6 hrs 40.625  (11.092452) 73.56  (12.108179) 108.86667  (16.846325)
t = 9 hrs 31.925  (12.673956) 78.7  (16.428025) 107.55  (6.8625797)
t = 12 hrs 23.7  (7.7948701) 78.816667  (17.543935) 104.9  (10.529008)
t = 12.5 hrs 21.766667  (6.7337459) 71.483333  (20.245238) 100.31667  (12.198429)
t = 14 hrs 20.333333  (3.6855574) 57.733333  (15.467471) 82.15  (15.394902)
t = 16 hrs 18.833333  (0.5507571) 38.366667  (13.245628) 61.3  (17.549473)
t = 18 hrs 18.766667  (1.5821926) 26.5  (10.654201) 43.433333  (14.76383)
t = 20 hrs 22.133333  (5.0895317) 19.238333  (7.7310036) 29.966667  (11.375178)
t = 24 hrs 30.766667  (4.5763887) 17.683333  (4.5845029) 22.783333  (7.0024043)
t = 30 hrs 30.266667  (11.83737) 15.983333  (3.8012717) 18.45  (5.9949145)
t = 36 hrs 20.7  (7.2297994) 13.403333  (6.1446128) 17.383333  (8.9302669)
t = 48 hrs 33.133333  (3.1817186) 32.44  (17.400661) 34.633333  (12.038383)
14.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)
Hide Description

Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo).

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 1 - 3, 6 Placebo Cohorts 4, 5 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 8 4 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: h*microgram/dL
AUC 0 - 12 289  (235) 334  (412) 546  (312) 890  (258) 1420  (316) 1590  (336) 2210  (402) 1770  (222)
AUC 0 - 4 126  (103) 107  (68.8) 235  (104) 329  (84.8) 471  (97.7) 305  (56) 426  (151) 590  (76.7)
AUC last 340  (206) 277  (409) 579  (265) 903  (261) 1460  (340) 2070  (639) 3000  (677) 1820  (263)
15.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)
Hide Description

Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP).

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: h*microgram/dL
675  (270) 1010  (190) 1650  (172) 2340  (565) 3150  (657) 1840  (263)
16.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])
Hide Description

Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP).

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: dL/hour
4.06  (1.2) 5.11  (0.99) 4.59  (0.464) 6.72  (1.63) 6.61  (1.5) 5.56  (0.938)
17.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)
Hide Description

Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo).

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 1 - 3, 6 Placebo Cohorts 4, 5 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 8 4 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: microgram/dL
62.6  (32.4) 44.3  (34.8) 113  (44.5) 151  (33.9) 228  (19.7) 177  (38.2) 251  (51.7) 261  (30.3)
18.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)
Hide Description

Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo).

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohorts 1 - 3, 6 Placebo Cohorts 4, 5 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 12 4 6 6 6 6 6 6
Median (Full Range)
Unit of Measure: hours
4.5
(0.5 to 6)
6
(4 to 6)
4.5
(2 to 9)
4.5
(4 to 4.5)
4.75
(4 to 6)
7.5
(6 to 12)
6
(4 to 12.1)
4.5
(4 to 4.5)
19.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)
Hide Description

Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP).

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: micrograms/dL/mg
45.3  (17.8) 30.2  (6.78) 30.4  (2.63) 11.8  (2.55) 12.5  (2.59) 26.1  (3.03)
20.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)
Hide Description

Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP).

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: 1/hour
0.544  (0.0788) 0.668  (0.281) 0.711  (0.423) 0.475  (0.262) 0.337  (0.114) 0.917  (0.688)
21.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)
Hide Description

Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP).

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description:
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hours
1.3  (0.187) 1.19  (0.476) 1.29  (0.721) 1.87  (1.08) 2.21  (0.549) 1.04  (0.505)
22.Secondary Outcome
Title Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)
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Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP).

There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Time Frame 48 hours
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Hide Analysis Population Description
The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Arm/Group Title Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
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A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: dL
7.65  (2.84) 8.43  (2.94) 8.59  (4.79) 16.6  (6.33) 20.8  (6.8) 8.33  (4.05)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohorts 1 - 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Hide Arm/Group Description A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5). A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours. A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
All-Cause Mortality
Cohorts 1 - 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohorts 1 - 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohorts 1 - 6 Placebo Cohort 1 SFP Cohort 2 SFP Cohort 3 SFP Cohort 4 SFP Cohort 5 SFP Cohort 6 SFP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/12 (25.00%)      0/6 (0.00%)      3/6 (50.00%)      2/6 (33.33%)      4/6 (66.67%)      0/6 (0.00%)      0/6 (0.00%)    
Gastrointestinal disorders               
nausea  0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
abdominal discomfort  1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
diarrhoea  1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
General disorders               
sensation of foreign body  0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
infusion site pain  1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
vessel puncture site hemorrhage  0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
infusion site swelling  1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations               
nasopharyngitis  0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders               
back pain  0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders               
headache  0/12 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  3 1/6 (16.67%)  1 3/6 (50.00%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0
dizziness  0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Reproductive system and breast disorders               
dysmenorrhoea  0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders               
hyperhidrosis  0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders               
flushing  0/12 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Senior Director, Clinical Research & Operations
Organization: Rockwell Medical
Phone: 248-960-9009
EMail: rd@rockwellmed.com
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Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01920854     History of Changes
Other Study ID Numbers: RMTI-SFP-9
First Submitted: June 28, 2013
First Posted: August 12, 2013
Results First Submitted: December 11, 2014
Results First Posted: December 19, 2014
Last Update Posted: January 26, 2015