At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double Blind, Three-Arm, Single Dose, Parallel Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar Drug), US Licenced Avastin® and EU Approved Avastin® in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating MB02 (Bevacizumab Biosimilar), EU approved Avastin®, and 1 other intervention for Healthy Volunteers. Completed, enrolled 115 participants across 1 site.
Detailed Summary
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety and immunogenicity profile of MB02 with US and EU 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 3mg/kg, administered as 90-minute infusion
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