A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects

Phase 1 Completed 123 enrolled Shanghai Henlius Biotech

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and German).

Timeline

Start: 2015-09-16
Primary completion: 2016-05-11
Completion: 2017-01-25

Outcome

Met primary endpoint

paper The GLSMRs and 90% CIs for AUCinf were: 0.950 (0.891-1.013), 0.914 (0.858-0.973) and 0.962 (0.902-1.025) for HLX02 versus CN-trastuzumab, HLX02 versus EU-trastuzumab and CN-trastuzumab versus EU-trastuzumab, respectively. PMID 33169186 ↗

Publications

Zhu X, Ding Y, Yu Y, Wang M, Zhou W, Wang J, Zhu X, Zhang H, Wang M, Chai K, Zhang X, Luk A, Jiang W, Liu S, Zhang Q. A Phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX02 to reference CN- and EU-sourced trastuzumab in healthy subjects. Cancer Chemother Pharmacol. 2021 Mar;87(3):349-359. doi: 10.1007/s00280-020-04196-9. Epub 2020 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HLX02	Unknown	2 mg/kg	Intravenous
Subject	HLX02	Unknown	4 mg/kg	Intravenous
Subject	HLX02	Unknown	6 mg/kg	Intravenous
Subject	HLX02	Unknown	8 mg/kg	Intravenous
Comparator	Trastuzumab	Monoclonal antibody	6 mg/kg	—

Indications

No indication recorded.