A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers
Status:
Completed
Trial end date:
2019-12-27
Target enrollment:
Participant gender:
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.