NCT04973722

A Study to Evaluate LY06006 and Prolia in Healthy Adults

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

Study Design: The study is a randomized, double-blind, parallel-group study in healthy adult male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection. A total of 168 healthy male subjects will be randomized 1:1 to receive a single subcutaneous (s.c.) injection of 60mg of either LY06006 ( LY06006 , 60 mg/1mL , Shandong Luye Pharmaceutical Co., Ltd.) or Prolia (60 mg / 1 mL , Amgen Inc.). During the entire study period, blood samples should be collected according to the Schedule of Assessments for pharmacokinetic, pharmacodynamic and immunogenicity analysis, and safety assessments should be conducted.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	LY06006	60 mg/1 ml, once every 6 months administered subcutaneously
DRUG	Prolia	60 mg/1 ml, once every 6 months administered subcutaneously

Timeline

• Start date: 2020-12-09
• Primary completion: 2021-04-10
• Completion: 2021-12-31
• First posted: 2021-07-22
• Last updated: 2021-07-22

Locations

1 site across 1 country: China