At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 141 enrolled
Drug / intervention
CT-P16 +2 moredrug
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 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Bevacizumab (CT-P16, EU-approved Avastin and US-licensed Avastin) in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating CT-P16, EU-approved Avastin, and 1 other intervention for Healthy. Completed, enrolled 141 participants across 3 sites.
Detailed Summary
This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg of each product to healthy male subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
First PostedAug 2017
Primary CompletionDec 2017
Study CompletionJan 2018
TodayJul 2026
First PostedAug 14, 2017
Enrollment StartAug 7, 2017
Primary CompletionDec 22, 2017
Study CompletionJan 17, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.9 years ago
Interventions
CT-P16drug
CT-P16 is a biosimilar product for Avastin
EU-approved Avastindrug
EU-approved Avastin
US-licensed Avastindrug
US-licensed Avastin