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Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02326233
Recruitment Status : Completed
First Posted : December 29, 2014
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Interventions Biological: Pen of SB5
Biological: PFS of SB5
Enrollment 190
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pen of SB5 PFS of SB5
Hide Arm/Group Description

Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)

Pen of SB5

PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)

PFS of SB5

Period Title: Overall Study
Started 95 95
Completed 95 94
Not Completed 0 1
Arm/Group Title Pen of SB5 PFS of SB5 Total
Hide Arm/Group Description

Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)

Pen of SB5

PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)

PFS of SB5

Total of all reporting groups
Overall Number of Baseline Participants 95 95 190
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 95 participants 190 participants
31.2  (10.58) 30.5  (11.41) 30.8  (10.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 95 participants 190 participants
Female
9
   9.5%
10
  10.5%
19
  10.0%
Male
86
  90.5%
85
  89.5%
171
  90.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 95 participants 190 participants
Hispanic or Latino
5
   5.3%
3
   3.2%
8
   4.2%
Not Hispanic or Latino
90
  94.7%
92
  96.8%
182
  95.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 95 participants 190 participants
American Indian or Alaska Native
1
   1.1%
1
   1.1%
2
   1.1%
Asian
6
   6.3%
8
   8.4%
14
   7.4%
Native Hawaiian or Other Pacific Islander
1
   1.1%
4
   4.2%
5
   2.6%
Black or African American
3
   3.2%
1
   1.1%
4
   2.1%
White
78
  82.1%
80
  84.2%
158
  83.2%
More than one race
6
   6.3%
1
   1.1%
7
   3.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 95 participants 95 participants 190 participants
177.63  (7.753) 177.89  (7.814) 177.76  (7.764)
1.Primary Outcome
Title Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Hide Description [Not Specified]
Time Frame 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pen of SB5 PFS of SB5
Hide Arm/Group Description:

Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)

Pen of SB5

PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)

PFS of SB5

Overall Number of Participants Analyzed 94 94
Mean (Standard Deviation)
Unit of Measure: h·μg/mL
2743.2  (1081.76) 2503.3  (1043.69)
2.Primary Outcome
Title Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Hide Description [Not Specified]
Time Frame 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pen of SB5 PFS of SB5
Hide Arm/Group Description:

Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)

Pen of SB5

PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)

PFS of SB5

Overall Number of Participants Analyzed 94 94
Mean (Standard Deviation)
Unit of Measure: h·μg/mL
2329.2  (733.30) 2182.2  (724.98)
3.Primary Outcome
Title Maximum Serum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pen of SB5 PFS of SB5
Hide Arm/Group Description:

Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)

Pen of SB5

PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)

PFS of SB5

Overall Number of Participants Analyzed 94 94
Mean (Standard Deviation)
Unit of Measure: μg/mL
3.803  (1.0697) 3.673  (0.8810)
4.Secondary Outcome
Title Time to Reach Cmax (Tmax)
Hide Description [Not Specified]
Time Frame 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pen of SB5 PFS of SB5
Hide Arm/Group Description:

Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)

Pen of SB5

PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)

PFS of SB5

Overall Number of Participants Analyzed 94 94
Median (Full Range)
Unit of Measure: h
168.000
(24.00 to 504.12)
168.000
(48.00 to 408.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pen of SB5 PFS of SB5
Hide Arm/Group Description

Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)

Pen of SB5

PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)

PFS of SB5

All-Cause Mortality
Pen of SB5 PFS of SB5
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pen of SB5 PFS of SB5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/95 (1.05%)      2/94 (2.13%)    
Injury, poisoning and procedural complications     
Clavicle fracture   0/95 (0.00%)  0 1/94 (1.06%)  1
Hand fracture   0/95 (0.00%)  0 1/94 (1.06%)  1
Psychiatric disorders     
Schizophrenia   1/95 (1.05%)  1 0/94 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pen of SB5 PFS of SB5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/95 (41.05%)      28/94 (29.79%)    
General disorders     
Fatigue   7/95 (7.37%)  7 1/94 (1.06%)  1
Vessel puncture site bruise   5/95 (5.26%)  5 0/94 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection   15/95 (15.79%)  15 18/94 (19.15%)  19
Musculoskeletal and connective tissue disorders     
Back pain   6/95 (6.32%)  7 1/94 (1.06%)  1
Nervous system disorders     
Headache   6/95 (6.32%)  6 8/94 (8.51%)  10
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: Director of Clinical Trials
Organization: Samsung Bioepis Co., Ltd.
EMail: sbregistry@samsung.com
Layout table for additonal information
Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02326233     History of Changes
Other Study ID Numbers: SB5-G12-NHV
2014-005178-12 ( EudraCT Number )
First Submitted: December 22, 2014
First Posted: December 29, 2014
Results First Submitted: May 14, 2018
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019