A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with Avastin^® (EU and US) in healthy male subjects.

ABSTRACT:

Aim

The aim of this study was to compare the pharmacokinetics (PK) of DRL_BZ with that of EU-approved (reference medicinal product; RMP) and US-licensed (reference product; RP) bevacizumab (Avastin^® ) in healthy male subjects.

Methods

In this double-blind, parallel-group, Phase 1 study (BZ-01-001), men aged 20-45 years were randomized 1:1:1 to receive a single intravenous infusion of 1 mg kg^-1 of bevacizumab as DRL_BZ, RMP or RP. A total of 149 subjects were randomized (DRL_BZ, 50; RMP, 50; RP, 49). Primary endpoints included maximum observed serum concentration (C_max ), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity (AUC_(0-∞) ), and area under the concentration-time curve from time zero

SUBMITTER: Wynne C 

PROVIDER: S-EPMC6138499 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature