At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 189 enrolled
Drug / intervention
SB5 +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-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Adalimumab (SB5, EU Sourced Humira® and US Sourced Humira®) in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating SB5, EU sourced Humira®, and 1 other intervention for Healthy. Completed, enrolled 189 participants across 1 site.
Detailed Summary
The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedMay 2014
Primary CompletionSep 2014
TodayJul 2026
First PostedMay 22, 2014
Enrollment StartMay 1, 2014
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.1 years ago
Interventions
SB5biological
EU sourced Humira®biological
US sourced Humira®biological