At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating MB02 (Bevacizumab Biosimilar) and EU approved Avastin® for Healthy Volunteers and 2 related conditions. Completed, enrolled 49 participants across 1 site.
Detailed Summary
A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy Male Volunteers. 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 3mg/kg, administered as 90- minute infusion
Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion