At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 159 enrolled
Drug / intervention
SB2 +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 Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating SB2, EU Remicade, and 1 other intervention for Healthy. Completed, enrolled 159 participants across 1 site.
Detailed Summary
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedAug 2013
Primary CompletionOct 2013
TodayJul 2026
First PostedAug 14, 2013
Enrollment StartJul 1, 2013
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.9 years ago
Interventions
SB2biological
IV infusion
EU Remicadebiological
IV infusion
US Remicadebiological
IV infusion