At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 119 enrolled
Drug / intervention
SB8 +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 Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating SB8, EU sourced Avastin®, and 1 other intervention for Healthy. Completed, enrolled 119 participants across 1 site.
Detailed Summary
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedMay 2015
Primary CompletionSep 2015
TodayJul 2026
First PostedMay 25, 2015
Enrollment StartApr 1, 2015
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.1 years ago
Interventions
SB8biological
SB8, proposed bevacizumab biosimilar
EU sourced Avastin®biological
EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
US Sourced Avastin®biological
US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)