Status:
COMPLETED
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
Lead Sponsor:
Samsung Bioepis Co., Ltd.
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.
Detailed Description
* Part A: Comparison between SB4 and EU sourced Enbrel * Part B: Comparison between SB4 and US sourced Enbrel * Part C: Comparison between EU sourced Enbrel and US sourced Enbrel
Eligibility Criteria
Inclusion
- Healthy male subjects
- Have a body weight between 60 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.
Exclusion
- 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 TB.
- 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 first administration of IP.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT01865552
Start Date
May 1 2013
End Date
August 1 2013
Last Update
June 4 2019
Active Locations (1)
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1
Parexel International GmbH
Berlin, Germany