Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
NCT ID: NCT01865552
Last Updated: 2019-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
138 participants
INTERVENTIONAL
2013-05-31
2013-08-31
Brief Summary
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Detailed Description
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* Part B: Comparison between SB4 and US sourced Enbrel
* Part C: Comparison between EU sourced Enbrel and US sourced Enbrel
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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SB4 and EU sourced Enbrel in Part A
SB4 followed by EU sourced Enbrel
SB4
SC administration
EU sourced Enbrel
SC administration
EU sourced Enbrel and SB4 in Part A
EU sourced Enbrel followed by SB4
SB4
SC administration
EU sourced Enbrel
SC administration
SB4 and US sourced Enbrel in Part B
SB4 followed by US sourced Enbrel
SB4
SC administration
US sourced Enbrel
SC administration
US sourced Enbrel and SB4 in Part B
US sourced Enbrel followed by SB4
SB4
SC administration
US sourced Enbrel
SC administration
EU and US sourced Enbrel in Part C
EU sourced Enbrel followed by US sourced Enbrel
EU sourced Enbrel
SC administration
US sourced Enbrel
SC administration
US and EU sourced Enbrel in Part C
US sourced Enbrel followed by EU sourced Enbrel
EU sourced Enbrel
SC administration
US sourced Enbrel
SC administration
Interventions
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SB4
SC administration
EU sourced Enbrel
SC administration
US sourced Enbrel
SC administration
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
55 Years
MALE
Yes
Sponsors
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Samsung Bioepis Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Rainard Fuhr, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Parexel
Locations
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Parexel International GmbH
Berlin, , Germany
Countries
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Other Identifiers
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2012-004371-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SB4-G11-NHV
Identifier Type: -
Identifier Source: org_study_id
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