NCT06095427

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

A Randomized, Double Blind, Three-Arm, Parallel Group, 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: Male
• Age: 28 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	LY06006 (Denosumab Biosimilar)	single dose of 60 mg LY006006 s.c.
BIOLOGICAL	US-Prolia (Denosumab)	single dose of 60 mg US-Prolia s.c.
BIOLOGICAL	EU-Prolia	single dose of 60 mg EU-Prolia s.c.

Timeline

• Start date: 2021-03-09
• Primary completion: 2023-03-14
• Completion: 2023-03-14
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

2 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study