To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects

Summary

The purpose of this study is to compare the pharmacokinetics, as well as to evaluate the safety, tolerability and immunogenicity of HD204, US-Avastin and EU-Avastin in healthy male subjects after intravenous administration of a single dose..

Timeline

Start

2018-09-19

Primary completion

2019-03-13

Completion

2019-03-13

Outcome

Met primary endpoint

paper were all within the interval of 80% to 125% for AUC0-inf, thus demonstrating equivalency PMID 34555031 ↗

paper AUC0-last and Cmax were all within the 80% and 125% margins PMID 34555031 ↗

Publications

• Demarchi M, Coliat P, Barthelemy P, Schott R, BenAbdelghani M, Kim M, Hii JCS, Feyaerts P, Ang FRX, Derde MP, Deforce F, Petit T, Schwabe C, Wynne C, Park LS, Pivot X. A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab. PLoS One. 2021 Sep 23;16(9):e0248222. doi: 10.1371/journal.pone.0248222. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	HD204	Unknown	1 mg/kg	Intravenous

Indications

No indication recorded.