At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 109 enrolled
Drug / intervention
SB3 +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, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Trastuzumab (SB3, EU Sourced Herceptin® and US Sourced Herceptin®) in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating SB3, EU sourced Herceptin®, and 1 other intervention for Healthy. Completed, enrolled 109 participants across 1 site.
Detailed Summary
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
First PostedMar 2014
Primary CompletionApr 2014
TodayJul 2026
First PostedMar 3, 2014
Enrollment StartFeb 1, 2014
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.3 years ago
Interventions
SB3biological
EU sourced Herceptin®biological
US sourced Herceptin®biological