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Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 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: NCT02144714
Recruitment Status : Completed
First Posted : May 22, 2014
Results First Posted : September 21, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition Healthy
Interventions Biological: SB5
Biological: EU sourced Humira®
Biological: US sourced Humira®
Enrollment 189
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SB5 (Proposed Adalimumab Biosimilar) EU Sourced Humira® US Sourced Humira®
Hide Arm/Group Description

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

SB5

EU sourced Humira®

EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

SB5

US sourced Humira®

US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

EU sourced Humira®

US sourced Humira®

Period Title: Overall Study
Started 63 63 63
Completed 63 63 63
Not Completed 0 0 0
Arm/Group Title SB5 (Proposed Adalimumab Biosimilar) EU Sourced Humira® US Sourced Humira® Total
Hide Arm/Group Description

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

SB5

EU sourced Humira®

EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

SB5

US sourced Humira®

US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

EU sourced Humira®

US sourced Humira®

Total of all reporting groups
Overall Number of Baseline Participants 63 63 63 189
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 63 participants 63 participants 189 participants
38.3  (9.55) 40.2  (11.06) 40.0  (10.94) 39.5  (10.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 63 participants 63 participants 189 participants
Female
4
   6.3%
5
   7.9%
6
   9.5%
15
   7.9%
Male
59
  93.7%
58
  92.1%
57
  90.5%
174
  92.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 63 participants 63 participants 63 participants 189 participants
White
61
  96.8%
60
  95.2%
62
  98.4%
183
  96.8%
Asian
0
   0.0%
2
   3.2%
0
   0.0%
2
   1.1%
Black or African American
2
   3.2%
0
   0.0%
1
   1.6%
3
   1.6%
Mixed
0
   0.0%
1
   1.6%
0
   0.0%
1
   0.5%
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 63 participants 63 participants 63 participants 189 participants
177.8  (6.72) 177.5  (6.34) 177.0  (6.68) 177.4  (6.56)
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 63 participants 63 participants 63 participants 189 participants
78.83  (7.163) 78.19  (6.388) 78.12  (6.458) 78.38  (6.651)
BMI (kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 63 participants 63 participants 63 participants 189 participants
24.98  (2.301) 24.82  (1.823) 24.97  (1.959) 24.93  (2.028)
1.Primary Outcome
Title Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Hide Description pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Time Frame 0 to 1680 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
Arm/Group Title SB5 (Proposed Adalimumab Biosimilar) EU Sourced Humira® US Sourced Humira®
Hide Arm/Group Description:

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

SB5

EU sourced Humira®

EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

SB5

US sourced Humira®

US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

EU sourced Humira®

US sourced Humira®

Overall Number of Participants Analyzed 53 61 57
Mean (Standard Deviation)
Unit of Measure: μg·h/mL
2405.6  (825.93) 2435.5  (915.66) 2422.6  (957.00)
2.Primary Outcome
Title Maximum Serum Concentration (Cmax)
Hide Description pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Time Frame pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
Arm/Group Title SB5 (Proposed Adalimumab Biosimilar) EU Sourced Humira® US Sourced Humira®
Hide Arm/Group Description:

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

SB5

EU sourced Humira®

EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

SB5

US sourced Humira®

US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

EU sourced Humira®

US sourced Humira®

Overall Number of Participants Analyzed 53 61 57
Mean (Standard Deviation)
Unit of Measure: μg/mL
3.365  (0.9796) 3.548  (1.1811) 3.488  (1.0779)
3.Primary Outcome
Title Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Hide Description pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Time Frame 0 to 1680 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
Arm/Group Title SB5 (Proposed Adalimumab Biosimilar) EU Sourced Humira® US Sourced Humira®
Hide Arm/Group Description:

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

SB5

EU sourced Humira®

EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

SB5

US sourced Humira®

US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

EU sourced Humira®

US sourced Humira®

Overall Number of Participants Analyzed 53 61 57
Mean (Standard Deviation)
Unit of Measure: μg·h/mL
2125.7  (689.92) 2096.0  (791.28) 2101.9  (795.56)
4.Secondary Outcome
Title Time to Cmax (Tmax)
Hide Description pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Time Frame pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
Arm/Group Title SB5 (Proposed Adalimumab Biosimilar) EU Sourced Humira® US Sourced Humira®
Hide Arm/Group Description:

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

SB5

EU sourced Humira®

EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

SB5

US sourced Humira®

US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

EU sourced Humira®

US sourced Humira®

Overall Number of Participants Analyzed 53 61 57
Mean (Standard Deviation)
Unit of Measure: h
165.962  (89.2503) 149.715  (76.6421) 166.456  (79.9227)
Time Frame The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SB5 (Proposed Adalimumab Biosimilar) EU Sourced Humira® US Sourced Humira®
Hide Arm/Group Description

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

SB5

EU sourced Humira®

EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

SB5

US sourced Humira®

US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

EU sourced Humira®

US sourced Humira®

All-Cause Mortality
SB5 (Proposed Adalimumab Biosimilar) EU Sourced Humira® US Sourced Humira®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
SB5 (Proposed Adalimumab Biosimilar) EU Sourced Humira® US Sourced Humira®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/63 (1.59%)      0/63 (0.00%)      1/63 (1.59%)    
Infections and infestations       
Appendicitis   0/63 (0.00%)  0 0/63 (0.00%)  0 1/63 (1.59%)  1
Psychiatric disorders       
Psychotic disorder   1/63 (1.59%)  1 0/63 (0.00%)  0 0/63 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SB5 (Proposed Adalimumab Biosimilar) EU Sourced Humira® US Sourced Humira®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/63 (46.03%)      17/63 (26.98%)      25/63 (39.68%)    
Infections and infestations       
Nasopharyngitis   12/63 (19.05%)  12 8/63 (12.70%)  8 11/63 (17.46%)  11
Oral herpes   4/63 (6.35%)  4 1/63 (1.59%)  1 4/63 (6.35%)  4
Rhinitis   2/63 (3.17%)  2 4/63 (6.35%)  4 3/63 (4.76%)  3
Nervous system disorders       
Headache   11/63 (17.46%)  15 4/63 (6.35%)  4 7/63 (11.11%)  7
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: Samsung Bioepis
Organization: Samsung Bioepis
Phone: +82 31 8061 4534
EMail: sbregistry@samsung.com
Layout table for additonal information
Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02144714    
Other Study ID Numbers: SB5-G11-NHV
2013-005332-15 ( EudraCT Number )
First Submitted: May 20, 2014
First Posted: May 22, 2014
Results First Submitted: January 11, 2018
Results First Posted: September 21, 2018
Last Update Posted: November 14, 2018