Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

Phase 1 Unknown 154 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.

RandomizedParallel-groupDouble-blindPrevention

Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）and Xgeva® in healthy adults.

Timeline

Start: 2020-09-01
Primary completion: 2021-06-30
Completion: 2021-06-30

Outcome

Met primary endpoint

paper Cmax, AUC0-t, and AUC0-∞ were 90.49 ~ 100.23%, 94.45 ~ 104.61%, and 94.08 ~ 105.23%, respectively, achieving the bioequivalence criteria of 80 ~ 125%. PMID 36112084 ↗

Publications

Lin Y, Yang H, Yang X, Guo C, Yang S, Yang G, Wu Q, Pan C, Sun C, Li C, He L, Huang J, Pei Q. Biosimilarity of HS-20090 to Denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study. Expert Opin Investig Drugs. 2022 Oct;31(10):1125-1132. doi: 10.1080/13543784.2022.2123737. Epub 2022 Sep 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Denosumab	Monoclonal antibody	120 mg	Subcutaneous
Subject	HS-20090	Monoclonal antibody	120 mg	Subcutaneous