A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the European Union, and China in healthy Chinese male volunteers.

ABSTRACT:

Purpose

To compare the pharmacokinetic profiles, safety and immunogenicity of proposed bevacizumab biosimilar HLX04 with reference bevacizumab in healthy Chinese males.

Methods

In this double-blind Phase 1 study, healthy volunteers (N = 208) were randomized 1:1:1:1 to a single 3 mg/kg intravenous infusion of HLX04 or reference bevacizumab sourced from the United States (bevacizumab-US), the European Union (bevacizumab-EU) or China (bevacizumab-CN). Co-primary endpoints were area under the serum concentration-time profile (AUC) from time zero extrapolated to infinity (AUC_0-inf) and from zero to last quantifiable concentration (AUC_last). Secondary endpoint was the maximum serum drug concentration (C_max). Study participants were monitored for tr

SUBMITTER: Zhu X 

PROVIDER: S-EPMC8316231 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature