Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects

Summary

This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.

Timeline

Start

2020-07-01

Primary completion

2021-07-01

Completion

2021-07-30

Outcome

Met primary endpoint

paper The 90% CIs of the geometric mean ratios of the primary endpoints were all within the prespecified equivalence margins PMID 35594017 ↗

release “In November 2021, the phase 1 clinical trial of HLX11 met its primary endpoint” henlius.com ↗

Publications

• Results American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available.
• Yang J, Lin L, Long Q, Zhang Q, Sun G, Zhou L, Wang Q, Zhu J, Li F, Hu W. HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects. BioDrugs. 2022 May;36(3):393-409. doi: 10.1007/s40259-022-00534-w. Epub 2022 May 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HLX11	Monoclonal antibody	420 mg	Intravenous
Comparator	Pertuzumab	Monoclonal antibody	420 mg	Intravenous

Indications

No indication recorded.