A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection

Summary

This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study. The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare safety, immunogenicity and pharmacodynamics (PD) between the test product L06006 and the reference products US-Prolia and EU-Prolia in healthy male subjects. A total of 300 healthy male subjects aged 28 to 65 years (both inclusive) will be randomized 1:1:1 to receive a single subcutaneous (s.c.) injection of either LY06006 or US-Prolia or EU-Prolia on Day 1 and then be followed for 36 weeks.

Timeline

Start

2021-03-09

Primary completion

2023-03-14

Completion

2023-03-14

Publications

• Fuhr R, Sun X, Wang X, Dong Y, Tai J, Zhou M, Dou C. A three-arm clinical study to compare pharmacokinetic and pharmacodynamic similarity of the denosumab biosimilar LY06006 with reference denosumab in healthy male subjects. Expert Opin Drug Metab Toxicol. 2024 Nov 24:1-9. doi: 10.1080/17425255.2024.2432673. Online ahead of print.

Drugs

Indications

No indication recorded.