A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers

Phase 1 Completed 49 enrolled mAbxience Research S.L.

RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start: 2019-08-02
Primary completion: 2019-12-27
Completion: 2019-12-27

Outcome

Met primary endpoint

paper the 90% confidence interval for the geometric means ratio for the primary PK endpoint, AUC0-∞, was within the predefined equivalence range (0.981-1.11). PMID 34269848 ↗

Publications

Eto T, Karasuyama Y, Gonzalez V, Del Campo Garcia A. A randomized, single-dose, pharmacokinetic equivalence study comparing MB02 (proposed biosimilar) and reference bevacizumab in healthy Japanese male volunteers. Cancer Chemother Pharmacol. 2021 Oct;88(4):713-722. doi: 10.1007/s00280-021-04324-z. Epub 2021 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	MB02	Unknown	3 mg/kg	Intravenous

Indications

No indication recorded.