At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 138 enrolled
Drug / intervention
SB4 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Single-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel® and US Sourced Enbrel®) in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating SB4, EU sourced Enbrel, and 1 other intervention for Healthy. Completed, enrolled 138 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2013
First PostedMay 2013
Primary CompletionAug 2013
TodayJul 2026
First PostedMay 31, 2013
Enrollment StartMay 1, 2013
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.1 years ago
Interventions
SB4biological
SC administration
EU sourced Enbrelbiological
SC administration
US sourced Enbrelbiological
SC administration