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Trial record 3 of 4 for:    SB4

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male 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: NCT01865552
Recruitment Status : Completed
First Posted : May 31, 2013
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition Healthy
Interventions Biological: SB4
Biological: EU sourced Enbrel
Biological: US sourced Enbrel
Enrollment 138
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SB4 and EU Sourced Enbrel in Part A EU Sourced Enbrel and SB4 in Part A SB4 and US Sourced Enbrel in Part B US Sourced Enbrel and SB4 in Part B EU and US Sourced Enbrel in Part C US and EU Sourced Enbrel in Part C
Hide Arm/Group Description

SB4 (Period 1) followed by EU sourced Enbrel (Period 2)

SB4: SC administration

EU sourced Enbrel: SC administration

EU sourced Enbrel (Period 1) followed by SB4 (Period 2)

SB4: SC administration

EU sourced Enbrel: SC administration

SB4 (Period 1) followed by US sourced Enbrel (Period 2)

SB4: SC administration

US sourced Enbrel: SC administration

US sourced Enbrel (Period 1) followed by SB4 (Period 2)

SB4: SC administration

US sourced Enbrel: SC administration

EU sourced Enbrel (Period 1) followed by US sourced Enbrel (Period 2)

EU sourced Enbrel: SC administration

US sourced Enbrel: SC administration

US sourced Enbrel (Period 1) followed by EU sourced Enbrel (Period 2)

EU sourced Enbrel: SC administration

US sourced Enbrel: SC administration

Period Title: Period 1
Started 23 23 23 23 23 23
Discontinued From Period 1 1 0 0 1 3 1
Completed 22 23 23 22 20 22
Not Completed 1 0 0 1 3 1
Reason Not Completed
Adverse Event             1             0             0             1             1             1
Pathological lab             0             0             0             0             1             0
Other             0             0             0             0             1             0
Period Title: Period 2
Started 22 23 23 22 20 22
Completed 22 23 23 22 20 22
Not Completed 0 0 0 0 0 0
Arm/Group Title SB4 and EU Sourced Enbrel in Part A EU Sourced Enbrel and SB4 in Part A SB4 and US Sourced Enbrel in Part B US Sourced Enbrel and SB4 in Part B EU and US Sourced Enbrel in Part C US and EU Sourced Enbrel in Part C Total
Hide Arm/Group Description

SB4 followed by EU sourced Enbrel

SB4: SC administration

EU sourced Enbrel: SC administration

EU sourced Enbrel followed by SB4

SB4: SC administration

EU sourced Enbrel: SC administration

SB4 followed by US sourced Enbrel

SB4: SC administration

US sourced Enbrel: SC administration

US sourced Enbrel followed by SB4

SB4: SC administration

US sourced Enbrel: SC administration

EU sourced Enbrel followed by US sourced Enbrel

EU sourced Enbrel: SC administration

US sourced Enbrel: SC administration

US sourced Enbrel followed by EU sourced Enbrel

EU sourced Enbrel: SC administration

US sourced Enbrel: SC administration

Total of all reporting groups
Overall Number of Baseline Participants 23 23 23 23 23 23 138
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 23 participants 23 participants 23 participants 23 participants 23 participants 138 participants
38  (9.4) 41  (10.9) 38  (9.7) 43  (8.9) 40  (10.5) 41  (9.4) 40  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 23 participants 23 participants 23 participants 23 participants 138 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
23
 100.0%
23
 100.0%
23
 100.0%
23
 100.0%
23
 100.0%
23
 100.0%
138
 100.0%
1.Primary Outcome
Title Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Hide Description pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Time Frame 0 to 480 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 SB4 in Part A EU Sourced Enbrel in Part A SB4 in Part B US Sourced Enbrel in Part B EU Sourced Enbrel in Part C US Sourced Enbrel in Part C
Hide Arm/Group Description:
SB4: SC administration
EU sourced Enbrel: SC administration
SB4: SC administration
US sourced Enbrel: SC administration
EU sourced Enbrel: SC administration
US sourced Enbrel: SC administration
Overall Number of Participants Analyzed 42 42 44 44 42 42
Mean (Standard Deviation)
Unit of Measure: µg·h/mL
769.069  (243.9039) 771.680  (226.2874) 834.680  (242.7652) 810.054  (195.9770) 790.110  (274.2535) 768.228  (238.1251)
2.Primary Outcome
Title Maximum Serum Concentration (Cmax)
Hide Description pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose.
Time Frame 0 to 480 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 SB4 in Part A EU Sourced Enbrel in Part A SB4 in Part B US Sourced Enbrel in Part B EU Sourced Enbrel in Part C US Sourced Enbrel in Part C
Hide Arm/Group Description:
SB4: SC administration
EU sourced Enbrel: SC administration
SB4: SC administration
US sourced Enbrel: SC administration
EU sourced Enbrel: SC administration
US sourced Enbrel: SC administration
Overall Number of Participants Analyzed 42 42 44 44 42 42
Mean (Standard Deviation)
Unit of Measure: μg/mL
3.607  (1.4298) 3.435  (1.2390) 3.869  (1.3251) 3.613  (1.0252) 3.720  (1.5444) 3.575  (1.4833)
3.Secondary Outcome
Title Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Hide Description pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Time Frame 0 to 480 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 SB4 in Part A EU Sourced Enbrel in Part A SB4 in Part B US Sourced Enbrel in Part B EU Sourced Enbrel in Part C US Sourced Enbrel in Part C
Hide Arm/Group Description:
SB4: SC administration
EU sourced Enbrel: SC administration
SB4: SC administration
US sourced Enbrel: SC administration
EU sourced Enbrel: SC administration
US sourced Enbrel: SC administration
Overall Number of Participants Analyzed 42 42 44 44 42 42
Mean (Standard Deviation)
Unit of Measure: µg·h/mL
728.169  (234.7621) 734.015  (220.2722) 788.773  (232.4636) 765.187  (184.5046) 752.277  (259.2088) 727.820  (229.8597)
4.Secondary Outcome
Title Time to Cmax (Tmax)
Hide Description pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Time Frame 0 to 480 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 SB4 in Part A EU Sourced Enbrel in Part A SB4 in Part B US Sourced Enbrel in Part B EU Sourced Enbrel in Part C US Sourced Enbrel in Part C
Hide Arm/Group Description:
SB4: SC administration
EU sourced Enbrel: SC administration
SB4: SC administration
US sourced Enbrel: SC administration
EU sourced Enbrel: SC administration
US sourced Enbrel: SC administration
Overall Number of Participants Analyzed 42 42 44 44 42 42
Mean (Standard Deviation)
Unit of Measure: h
75.198  (29.1358) 71.711  (24.7538) 75.263  (30.8374) 70.385  (22.4972) 70.276  (30.3826) 71.150  (29.7904)
Time Frame 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SB4 in Part A EU Sourced Enbrel in Part A SB4 in Part B US Sourced Enbrel in Part B EU Sourced Enbrel in Part C US Sourced Enbrel in Part C
Hide Arm/Group Description SB4: SC administration EU sourced Enbrel: SC administration SB4: SC administration US sourced Enbrel: SC administration EU sourced Enbrel: SC administration US sourced Enbrel: SC administration
All-Cause Mortality
SB4 in Part A EU Sourced Enbrel in Part A SB4 in Part B US Sourced Enbrel in Part B EU Sourced Enbrel in Part C US Sourced Enbrel in Part C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/46 (0.00%)   0/46 (0.00%)   0/46 (0.00%)   0/46 (0.00%)   0/46 (0.00%) 
Hide Serious Adverse Events
SB4 in Part A EU Sourced Enbrel in Part A SB4 in Part B US Sourced Enbrel in Part B EU Sourced Enbrel in Part C US Sourced Enbrel in Part C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/46 (0.00%)   0/46 (0.00%)   0/46 (0.00%)   0/46 (0.00%)   0/46 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SB4 in Part A EU Sourced Enbrel in Part A SB4 in Part B US Sourced Enbrel in Part B EU Sourced Enbrel in Part C US Sourced Enbrel in Part C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/46 (39.13%)   16/46 (34.78%)   23/46 (50.00%)   20/46 (43.48%)   17/46 (36.96%)   14/46 (30.43%) 
Cardiac disorders             
Palpitations   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Eye disorders             
Conjunctivitis   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Gastrointestinal disorders             
Nausea   1/46 (2.17%)  2/46 (4.35%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Abdominal distension   1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Diarrhoea   0/46 (0.00%)  2/46 (4.35%)  1/46 (2.17%)  1/46 (2.17%)  1/46 (2.17%)  0/46 (0.00%) 
Lip erosion   0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Dyspepsia   0/46 (0.00%)  0/46 (0.00%)  2/46 (4.35%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Toothache   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%) 
Flatulence   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%) 
Aphthous stomatitis   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  1/46 (2.17%)  0/46 (0.00%) 
Lip blister   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Oral discomfort   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
General disorders             
Injection site reaction   2/46 (4.35%)  3/46 (6.52%)  3/46 (6.52%)  3/46 (6.52%)  1/46 (2.17%)  3/46 (6.52%) 
Chest discomfort   1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Asthenia   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Fatigue   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  2/46 (4.35%)  2/46 (4.35%) 
Influenza like illness   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%) 
Infections and infestations             
Nasopharyngitis   5/46 (10.87%)  2/46 (4.35%)  2/46 (4.35%)  2/46 (4.35%)  2/46 (4.35%)  1/46 (2.17%) 
Rhinitis   2/46 (4.35%)  2/46 (4.35%)  1/46 (2.17%)  1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%) 
Pharyngitis   1/46 (2.17%)  0/46 (0.00%)  2/46 (4.35%)  2/46 (4.35%)  0/46 (0.00%)  0/46 (0.00%) 
Oral herpes   0/46 (0.00%)  1/46 (2.17%)  1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Gastroenteritis   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Tooth abscess   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%) 
Folliculitis   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Injury, poisoning and procedural complications             
Arthropod bite   1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Traumatic haematoma   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Laceration   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%) 
Limb injury   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Injury   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Ligament rupture   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Investigations             
Alanine aminotransferase increased   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain   1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%)  3/46 (6.52%)  0/46 (0.00%)  0/46 (0.00%) 
Neck pain   1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Myalgia   0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Musculoskeletal chest pain   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Limb discomfort   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Nervous system disorders             
Headache   4/46 (8.70%)  2/46 (4.35%)  3/46 (6.52%)  4/46 (8.70%)  4/46 (8.70%)  3/46 (6.52%) 
Dizziness   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  3/46 (6.52%)  1/46 (2.17%)  0/46 (0.00%) 
Dizziness postural   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%) 
Paraesthesia   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%) 
Somnolence   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  1/46 (2.17%) 
Renal and urinary disorders             
Pollakiuria   0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Reproductive system and breast disorders             
Erection increased   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Epistaxis   1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Nasal congestion   1/46 (2.17%)  0/46 (0.00%)  1/46 (2.17%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%) 
Cough   0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Oropharyngeal pain   0/46 (0.00%)  0/46 (0.00%)  2/46 (4.35%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%) 
Sinus congestion   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%) 
Skin and subcutaneous tissue disorders             
Sunburn   1/46 (2.17%)  1/46 (2.17%)  1/46 (2.17%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%) 
Photosensitivity reaction   1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Skin fissures   0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%) 
Rash erythematous   0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%) 
Pruritus   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  1/46 (2.17%)  0/46 (0.00%) 
Dermatitis   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Eczema   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%) 
Vascular disorders             
Hot flush   0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  0/46 (0.00%)  1/46 (2.17%)  0/46 (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: Director of Clinical Development
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: NCT01865552    
Other Study ID Numbers: SB4-G11-NHV
2012-004371-39 ( EudraCT Number )
First Submitted: May 27, 2013
First Posted: May 31, 2013
Results First Submitted: October 8, 2018
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019