Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects

Phase 1 Completed 112 enrolled Shandong Boan Biotechnology Co., Ltd

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in healthy Chinese male subjects.

Timeline

Start: 2020-08-04
Primary completion: 2021-01-13
Completion: 2021-01-13

Outcome

Met primary endpoint

paper The 90% CIs of the GMRs of AUC0-t, AUC0-∞, and Cmax of LY01008 to Avastin® were all within the bioequivalence margin. PMID 34913787 ↗

Publications

Zhou R, Yang J, Liu Y, Zhang Q, Lu C, Tang K, Li X, Tang W, Gao E, Wu C, Dou C, Hu W. A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin(R) in healthy Chinese male subjects. Expert Opin Biol Ther. 2022 Feb;22(2):263-269. doi: 10.1080/14712598.2022.2019703. Epub 2021 Dec 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	LY01008	Monoclonal antibody	3 mg/kg	Intravenous