At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Three-Arm, Single Dose, Parallel Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02-SP, MB02-DM (Bevacizumab Biosimilar Drugs) and US-licensed Avastin® in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating MB02-SP, MB02-DM, and 1 other intervention for Healthy Volunteers. Completed, enrolled 114 participants across 2 sites.
Detailed Summary
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, safety and immunogenicity profile of MB02-DM with MB02-SP and US-Avastin® in healthy male subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
Study Details
Timeline
Interventions
Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion