Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects

• Sponsor: Samsung Bioepis Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01922336
• Collaborator: (none)
• Enrollment: 159
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 52.6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: SB2; Biological: EU Remicade; Biological: US Remicade	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 159 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SB2 SB2 (Study drug)	Biological: SB2; IV infusion
Active Comparator: EU Remicade EU sourced Remicade (Reference drug)	Biological: EU Remicade; IV infusion
Active Comparator: US Remicade US sourced Remicade (Reference drug)	Biological: US Remicade; IV infusion

Outcome Measures

Primary Outcome Measures

1. Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) [71 days]

2. Maximum Serum Concentration (Cmax) [71 days]

3. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) [71 days]

Secondary Outcome Measures

1. Time to Cmax (Tmax) [71 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy female subjects of non-childbearing potential and healthy male subjects

• Have a body weight between 60.0 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.

Exclusion Criteria:

• history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.

• active or latent Tuberculosis or who have a history of Tuberculosis.

• history of invasive systemic fungal infections or other opportunistic infections

• systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process

• serious infection associated with hospitalisation and/or which required intravenous antibiotics

• history of and/or current cardiac disease

• have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.

• Intake medication with a half-life > 24 h within 1 month or 10 half-lives of the medication prior to the administration of investigational product.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parexel International GmbH	Berlin		Germany

Sponsors and Collaborators

• Samsung Bioepis Co., Ltd.

Investigators

• Principal Investigator: Rainard Fuhr, M.D., Ph.D., Parexel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Bioepis Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01922336
• Other Study ID Numbers: SB2-G11-NHV; 2012-005306-22
• First Posted: Aug 14, 2013
• Last Update Posted: Feb 21, 2019
• Last Verified: Oct 1, 2018

• Keywords provided by Samsung Bioepis Co., Ltd.: Pharmacokinetics
• Additional relevant MeSH terms: Infliximab

Study Results

Participant Flow

Arm/Group Title	SB2 (Proposed Infliximab Biosimilar)	EU Remicade	US Remicade
Arm/Group Description	SB2 (Study drug) SB2: IV infusion	EU sourced Remicade (Reference drug) EU Remicade: IV infusion	US sourced Remicade (Reference drug) US Remicade: IV infusion
Period Title: Overall Study
STARTED	53	53	53
COMPLETED	53	53	53
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	SB2 (Proposed Infliximab Biosimilar)	EU Remicade	US Remicade	Total
Arm/Group Description	SB2 (Study drug) SB2: IV infusion	EU sourced Remicade (Reference drug) EU Remicade: IV infusion	US sourced Remicade (Reference drug) US Remicade: IV infusion	Total of all reporting groups
Overall Participants	53	53	53	159
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.7 (9.67)	40.3 (9.72)	39.4 (9.87)	40.1 (9.71)
Sex: Female, Male (Count of Participants)
Female	4 7.5%	2 3.8%	3 5.7%	9 5.7%
Male	49 92.5%	51 96.2%	50 94.3%	150 94.3%
Race/Ethnicity, Customized (Count of Participants)
White	51 96.2%	52 98.1%	52 98.1%	155 97.5%
Asian	1 1.9%	0 0%	1 1.9%	2 1.3%
Black or African American	1 1.9%	0 0%	0 0%	1 0.6%
Other	0 0%	1 1.9%	0 0%	1 0.6%
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	24.56 (2.078)	25.39 (2.092)	24.79 (2.058)	24.91 (2.092)

Outcome Measures

1. Primary Outcome

Title	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time Frame	71 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SB2 (Proposed Infliximab Biosimilar)	EU Remicade	US Remicade
Arm/Group Description	SB2 (Study drug) SB2: IV infusion	EU sourced Remicade (Reference drug) EU Remicade: IV infusion	US sourced Remicade (Reference drug) US Remicade: IV infusion
Measure Participants	51	53	53
Mean (Standard Deviation) [h·μg/mL]	38702.8145 (11113.62172)	39359.7493 (12332.41615)	39270.1707 (10064.08853)

2. Primary Outcome

Title	Maximum Serum Concentration (Cmax)
Time Frame	71 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SB2 (Proposed Infliximab Biosimilar)	EU Remicade	US Remicade
Arm/Group Description	SB2 (Study drug) SB2: IV infusion	EU sourced Remicade (Reference drug) EU Remicade: IV infusion	US sourced Remicade (Reference drug) US Remicade: IV infusion
Measure Participants	51	53	53
Mean (Standard Deviation) [μg/mL]	126.9975 (16.89586)	126.2377 (17.88151)	129.1508 (18.75573)

3. Primary Outcome

Title	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time Frame	71 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SB2 (Proposed Infliximab Biosimilar)	EU Remicade	US Remicade
Arm/Group Description	SB2 (Study drug) SB2: IV infusion	EU sourced Remicade (Reference drug) EU Remicade: IV infusion	US sourced Remicade (Reference drug) US Remicade: IV infusion
Measure Participants	51	53	53
Mean (Standard Deviation) [h·μg/mL]	36862.4180 (9132.75342)	37022.3524 (9398.42182)	37367.5577 (8332.05331)

4. Secondary Outcome

Title	Time to Cmax (Tmax)
Time Frame	71 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SB2 (Proposed Infliximab Biosimilar)	EU Remicade	US Remicade
Arm/Group Description	SB2 (Study drug) SB2: IV infusion	EU sourced Remicade (Reference drug) EU Remicade: IV infusion	US sourced Remicade (Reference drug) US Remicade: IV infusion
Measure Participants	51	53	53
Mean (Standard Deviation) [hour]	2.9294 (1.11529)	2.5824 (0.95950)	2.7591 (1.03184)

Adverse Events

Arm/Group Title	SB2 (Proposed Infliximab Biosimilar)		EU Remicade		US Remicade
Arm/Group Description	SB2 (Study drug) SB2: IV infusion		EU sourced Remicade (Reference drug) EU Remicade: IV infusion		US sourced Remicade (Reference drug) US Remicade: IV infusion
All Cause Mortality
	SB2 (Proposed Infliximab Biosimilar)		EU Remicade		US Remicade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/53 (0%)		0/53 (0%)
Serious Adverse Events
	SB2 (Proposed Infliximab Biosimilar)		EU Remicade		US Remicade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/53 (3.8%)		0/53 (0%)		0/53 (0%)
Infections and infestations
Borrelia infection	1/53 (1.9%)	1	0/53 (0%)	0	0/53 (0%)	0
Injury, poisoning and procedural complications
Concussion	1/53 (1.9%)	1	0/53 (0%)	0	0/53 (0%)	0
Renal and urinary disorders
Renal cyst ruptured	1/53 (1.9%)	1	0/53 (0%)	0	0/53 (0%)	0
Other (Not Including Serious) Adverse Events
	SB2 (Proposed Infliximab Biosimilar)		EU Remicade		US Remicade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/53 (26.4%)		11/53 (20.8%)		13/53 (24.5%)
Gastrointestinal disorders
Diarrhoea	3/53 (5.7%)	3	2/53 (3.8%)	2	1/53 (1.9%)	1
Infections and infestations
Nasopharyngitis	6/53 (11.3%)	6	4/53 (7.5%)	4	13/53 (24.5%)	13
Rhinitis	3/53 (5.7%)	3	2/53 (3.8%)	2	1/53 (1.9%)	1
Nervous system disorders
Headache	5/53 (9.4%)	9	6/53 (11.3%)	8	7/53 (13.2%)	7
Skin and subcutaneous tissue disorders
Dry skin	3/53 (5.7%)	3	0/53 (0%)	0	1/53 (1.9%)	1

Limitations/Caveats

[Not Specified]

More Information

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.