Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
- Conditions
- Healthy
- Interventions
- Biological: SB4Biological: EU sourced EnbrelBiological: US sourced Enbrel
- Registration Number
- NCT01865552
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 138
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description US sourced Enbrel and SB4 in Part B SB4 US sourced Enbrel followed by SB4 US and EU sourced Enbrel in Part C US sourced Enbrel US sourced Enbrel followed by EU sourced Enbrel SB4 and US sourced Enbrel in Part B US sourced Enbrel SB4 followed by US sourced Enbrel EU and US sourced Enbrel in Part C EU sourced Enbrel EU sourced Enbrel followed by US sourced Enbrel SB4 and EU sourced Enbrel in Part A SB4 SB4 followed by EU sourced Enbrel SB4 and EU sourced Enbrel in Part A EU sourced Enbrel SB4 followed by EU sourced Enbrel EU sourced Enbrel and SB4 in Part A SB4 EU sourced Enbrel followed by SB4 EU sourced Enbrel and SB4 in Part A EU sourced Enbrel EU sourced Enbrel followed by SB4 SB4 and US sourced Enbrel in Part B SB4 SB4 followed by US sourced Enbrel US sourced Enbrel and SB4 in Part B US sourced Enbrel US sourced Enbrel followed by SB4 EU and US sourced Enbrel in Part C US sourced Enbrel EU sourced Enbrel followed by US sourced Enbrel US and EU sourced Enbrel in Part C EU sourced Enbrel US sourced Enbrel followed by EU sourced Enbrel
- Primary Outcome Measures
Name Time Method Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) 0 to 480 hours post-dose pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Maximum Serum Concentration (Cmax) 0 to 480 hours post-dose 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.
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) 0 to 480 hours post-dose pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Time to Cmax (Tmax) 0 to 480 hours post-dose pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Trial Locations
- Locations (1)
Parexel International GmbH
🇩🇪Berlin, Germany