NCT04940845

Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

A Randomized, Single-blinded and Parallel Study to Assess the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Shanghai Hansoh Biomedical Co., Ltd · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.

Detailed description

This is a phase I, single center, randomized, single-blind and parallel group clinical trial .The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	HS-20090-2	Subcutaneously injection of HS-20090-2 (60mg/1mL) once on the first day
DRUG	Prolia	Subcutaneously injection of Prolia® (60mg/1mL) once on the first day

Timeline

• Start date: 2021-07-26
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-06-28
• Last updated: 2021-08-25

Locations

1 site across 1 country: China