A Study to Evaluate LY06006 and Prolia in Healthy Adults

Phase 1 Unknown 168 enrolled Luye Pharma Group Ltd. Shandong Boan Biotechnology Co., Ltd · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

A randomized, double-blind, parallel-group study in Chinese healthy male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection

Timeline

Start: 2020-12-09
Primary completion: 2021-04-10
Completion: 2021-12-31

Publications

Wang S, Yang X, Huang J, Yang S, Wu Q, Chen H, Wu S, Dou C, Yang G, Xiang Y. Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a biosimilar of denosumab (LY06006): a randomized, double-blind, single-dose, parallel-controlled clinical study in healthy Chinese subjects. Expert Opin Investig Drugs. 2022 Oct;31(10):1133-1142. doi: 10.1080/13543784.2022.2120389. Epub 2022 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Denosumab	Monoclonal antibody	60 mg	Subcutaneous
Subject	LY06006	Monoclonal antibody	60 mg	Subcutaneous

Indications

No indication recorded.