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Trial record 1 of 4 for:    ACE-083
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Phase 1 Study of ACE-083 in Healthy Subjects

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: NCT02257489
Recruitment Status : Completed
First Posted : October 6, 2014
Results First Posted : July 8, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Acceleron Pharma, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Musculoskeletal Diseases
Intervention Drug: ACE-083
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 50 mg Single Dose (RF) 100 mg Single Dose (RF) 200 mg Single Dose (RF) 100 mg Multiple Dose (RF) 200 mg Multiple Dose (RF) 100 mg Multiple Dose (TA) 150 mg Multiple Dose (TA) Pooled Placebo (RF) Pooled Placebo (TA)
Hide Arm/Group Description

8 subjects in total; 6 subjects to receive ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

Pooled placebo from the rectus femoris (RF) cohorts, n=10 (n=2 from each RF cohort) Pooled placebo from the tibialis anterior cohorts, n=6 (n=3 from each TA cohort)
Period Title: Overall Study
Started 6 6 6 6 6 6 6 10 6
Completed 6 6 6 5 6 6 6 10 6
Not Completed 0 0 0 1 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             1             0             0             0             0             0
Arm/Group Title 50 mg Single Dose (RF) 100 mg Single Dose (RF) 200 mg Single Dose (RF) 100 mg Multiple Dose (RF) 200 mg Multiple Dose (RF) 100 mg Multiple Dose (TA) 150 mg Multiple Dose (TA) Pooled Placebo (RF) Pooled Placebo (TA) Total
Hide Arm/Group Description

8 subjects in total; 6 subjects to receive ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

Pooled placebo from the rectus femoris (RF) cohorts, n=10 (n=2 from each RF cohort) Pooled placebo from the tibialis anterior cohorts, n=6 (n=3 from each TA cohort) Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 6 10 6 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 10 participants 6 participants 58 participants
58.0  (4.29) 54.2  (9.99) 55.0  (2.37) 55.2  (3.71) 57.0  (2.45) 55.7  (3.08) 57.0  (4.73) 59.2  (5.53) 56.7  (7.50) 56.6  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 10 participants 6 participants 58 participants
Female
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
10
 100.0%
6
 100.0%
58
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 10 participants 6 participants 58 participants
Hispanic or Latino
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
3
   5.2%
Not Hispanic or Latino
6
 100.0%
5
  83.3%
6
 100.0%
5
  83.3%
6
 100.0%
5
  83.3%
6
 100.0%
10
 100.0%
6
 100.0%
55
  94.8%
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%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 10 participants 6 participants 58 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%
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%
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%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
2
   3.4%
White
6
 100.0%
6
 100.0%
6
 100.0%
5
  83.3%
6
 100.0%
6
 100.0%
6
 100.0%
10
 100.0%
5
  83.3%
56
  96.6%
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%
0
   0.0%
0
   0.0%
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%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title ACE-083 Safety and Tolerability: Number of Subjects With Adverse Events
Hide Description Safety/tolerability assessment, following intramuscular administration, includes adverse events, injection site reactions, laboratory measurements, vital signs, etc.
Time Frame From initiation of treatment (Study Day 1) to end of follow up period (up to Study Day 106)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50 mg Single Dose (RF) 100 mg Single Dose (RF) 200 mg Single Dose (RF) 100 mg Multiple Dose (RF) 200 mg Multiple Dose (RF) 100 mg Multiple Dose (TA) 150 mg Multiple Dose (TA) Pooled Placebo (RF) Pooled Placebo (TA)
Hide Arm/Group Description:

8 subjects in total; 6 subjects to receive ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

Pooled placebo from the rectus femoris (RF) cohorts, n=10 (n=2 from each RF cohort)
Pooled placebo from the tibialis anterior cohorts, n=6 (n=3 from each TA cohort)
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 10 6
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
10
 100.0%
6
 100.0%
2.Secondary Outcome
Title ACE-083 Pharmacokinetics: Maximum Measured Plasma Concentrations
Hide Description Assessment of systemic absorption and exposure following local injection of ACE-083 into the thigh or lower leg muscle
Time Frame PK samples were collected predose, and at 3 hours and 6 hours postdose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50 mg Single Dose (RF) 100 mg Single Dose (RF) 200 mg Single Dose (RF) 100 mg Multiple Dose (RF) 200 mg Multiple Dose (RF) 100 mg Multiple Dose (TA) 150 mg Multiple Dose (TA)
Hide Arm/Group Description:

8 subjects in total; 6 subjects to receive ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

Overall Number of Participants Analyzed 6 5 6 6 6 6 6
Measure Type: Number
Unit of Measure: ng/mL (Cmax)
Cmax (min) dose 1 0 0 0 0 0 0 0
Cmax (max) dose 1 0 168 226 112 219 132 136
3.Secondary Outcome
Title ACE-083 Pharmacodynamics
Hide Description Pharmacodynamic assessments include measurements of thigh or lower leg volume and composition (by MRI) and muscle strength testing (by hand-held dynamometer and fixed system)
Time Frame From initiation of treatment (Study Day 1) to end of follow up period (up to Study Day 106)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title ACE-083 Pharmacokinetics: Time of the Maximum Measured Plasma Concentration
Hide Description Assessment of systemic absorption and exposure following local injection of ACE-083 into the thigh or lower leg muscle
Time Frame PK samples were collected predose, and at 3 hours and 6 hours postdose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50 mg Single Dose (RF) 100 mg Single Dose (RF) 200 mg Single Dose (RF) 100 mg Multiple Dose (RF) 200 mg Multiple Dose (RF) 100 mg Multiple Dose (TA) 150 mg Multiple Dose (TA)
Hide Arm/Group Description:

8 subjects in total; 6 subjects to receive ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

Overall Number of Participants Analyzed 6 5 6 6 6 6 6
Measure Type: Number
Unit of Measure: h (Tmax)
Tmax (min) dose 1 0 96 96 96 600 24.00 96.0
Tmax (max) dose 1 0 96 168 96 600 96.0 96.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 50 mg Single Dose (RF) 100 mg Single Dose (RF) 200 mg Single Dose (RF) 100 mg Multiple Dose (RF) 200 mg Multiple Dose (RF) 100 mg Multiple Dose (TA) 150 mg Multiple Dose (TA) Pooled Placebo (RF) Pooled Placebo (TA)
Hide Arm/Group Description

8 subjects in total; 6 subjects to receive ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

9 subjects in total; 6 subjects to receive ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)

ACE-083: recombinant fusion protein

Pooled placebo from the rectus femoris (RF) cohorts, n=10 (n=2 from each RF cohort) Pooled placebo from the tibialis anterior cohorts, n=6 (n=3 from each TA cohort)
All-Cause Mortality
50 mg Single Dose (RF) 100 mg Single Dose (RF) 200 mg Single Dose (RF) 100 mg Multiple Dose (RF) 200 mg Multiple Dose (RF) 100 mg Multiple Dose (TA) 150 mg Multiple Dose (TA) Pooled Placebo (RF) Pooled Placebo (TA)
Affected / at Risk (%) Affected / at Risk (%) 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
50 mg Single Dose (RF) 100 mg Single Dose (RF) 200 mg Single Dose (RF) 100 mg Multiple Dose (RF) 200 mg Multiple Dose (RF) 100 mg Multiple Dose (TA) 150 mg Multiple Dose (TA) Pooled Placebo (RF) Pooled Placebo (TA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (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%)   0/10 (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 5%
50 mg Single Dose (RF) 100 mg Single Dose (RF) 200 mg Single Dose (RF) 100 mg Multiple Dose (RF) 200 mg Multiple Dose (RF) 100 mg Multiple Dose (TA) 150 mg Multiple Dose (TA) Pooled Placebo (RF) Pooled Placebo (TA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   10/10 (100.00%)   6/6 (100.00%) 
Ear and labyrinth disorders                   
Ear pain   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Ear discomfort   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Eye disorders                   
Dry eye   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Eye irritation   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders                   
Diarrhoea   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%) 
Dyspepsia   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Vomiting   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Nausea   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Gingival pain   0/6 (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%)  0/10 (0.00%)  1/6 (16.67%) 
General disorders                   
Injection site pain   5/6 (83.33%)  5/6 (83.33%)  6/6 (100.00%)  5/6 (83.33%)  6/6 (100.00%)  5/6 (83.33%)  6/6 (100.00%)  10/10 (100.00%)  6/6 (100.00%) 
Injection site haemorrhage   1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  3/6 (50.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Injection site reaction   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  3/6 (50.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%) 
Injection site discomfort   0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  3/6 (50.00%)  0/6 (0.00%)  3/6 (50.00%)  1/6 (16.67%)  1/10 (10.00%)  3/6 (50.00%) 
Fatigue   1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Chills   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Gait disturbance   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Injection site erythema   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Injection site warmth   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  2/10 (20.00%)  1/6 (16.67%) 
Pain   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Injection site hypoaesthesia   0/6 (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%)  1/10 (10.00%)  0/6 (0.00%) 
Injection site paresthesia   0/6 (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%)  1/10 (10.00%)  0/6 (0.00%) 
Discomfort   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  0/10 (0.00%)  2/6 (33.33%) 
Injection site oedema   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  0/10 (0.00%)  1/6 (16.67%) 
Pyrexia   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Injection site pruritus   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Local swelling   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Feeling hot   0/6 (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%)  0/10 (0.00%)  1/6 (16.67%) 
Infections and infestations                   
Oral herpes   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Nasopharyngitis   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications                   
Arthropod bite   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Ligament sprain   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Contusion   0/6 (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%)  1/10 (10.00%)  0/6 (0.00%) 
Nerve injury   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders                   
Increased appetite   0/6 (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%)  0/10 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders                   
Muscle twitching   0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  3/6 (50.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  3/10 (30.00%)  0/6 (0.00%) 
Myalgia   1/6 (16.67%)  0/6 (0.00%)  3/6 (50.00%)  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Pain in extremity   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  4/6 (66.67%)  2/6 (33.33%)  6/6 (100.00%)  6/6 (100.00%)  2/10 (20.00%)  5/6 (83.33%) 
Musculoskeletal stiffness   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  1/10 (10.00%)  1/6 (16.67%) 
Arthralgia   0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/10 (10.00%)  4/6 (66.67%) 
Joint stiffness   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Limb discomfort   0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/10 (20.00%)  0/6 (0.00%) 
Muscle tightness   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  2/6 (33.33%)  2/6 (33.33%)  1/10 (10.00%)  2/6 (33.33%) 
Muscle fatigue   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Muscle spasms   1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Muscular weakness   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Groin pain   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Nervous system disorders                   
Headache   3/6 (50.00%)  1/6 (16.67%)  2/6 (33.33%)  3/6 (50.00%)  0/6 (0.00%)  4/6 (66.67%)  2/6 (33.33%)  1/10 (10.00%)  1/6 (16.67%) 
Paresthesia   0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Migraine   1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Sinus headache   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Sensory disturbance   0/6 (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%)  1/10 (10.00%)  0/6 (0.00%) 
Aphonia   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Lethargy   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Hypoaesthesia   0/6 (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%)  0/10 (0.00%)  2/6 (33.33%) 
Reproductive system and breast disorders                   
Breast tenderness   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Sinus congestion   0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  1/6 (16.67%)  0/6 (0.00%)  3/6 (50.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%) 
Oropharyngeal pain   0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%) 
Productive cough   1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Rhinorrhoea   0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  0/10 (0.00%)  0/6 (0.00%) 
Cough   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%) 
Nasal congestion   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/10 (0.00%)  0/6 (0.00%) 
Throat irritation   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Upper respiratory tract congestion   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Dry throat   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Sneezing   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders                   
Pruritus   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Erythema   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Generalised erythema   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Dry skin   0/6 (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%)  1/10 (10.00%)  0/6 (0.00%) 
Skin odour abnormal   0/6 (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%)  1/10 (10.00%)  0/6 (0.00%) 
Skin tightness   0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Kenneth M. Attie, MD
Organization: Acceleron Pharma, Inc.
Phone: 617-649-9200
EMail: kattie@acceleronpharma.com
Layout table for additonal information
Responsible Party: Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02257489     History of Changes
Other Study ID Numbers: A083-01
First Submitted: October 2, 2014
First Posted: October 6, 2014
Results First Submitted: October 30, 2018
Results First Posted: July 8, 2019
Last Update Posted: July 24, 2019