NCT04534582

Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects

A Randomised, Parallel, Single-Dose, Subcutaneous Injection, Phase I Clinical Study Of HLX14 Versus Prolia® (Denosumab) In Chinese Healthy Adult Male Subjects For Comparison In Pharmacokinetic Characteristics, Safety, And Immunogenicity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: Male
• Age: 28 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Part I of the study： This is a randomised, single-dose, subcutaneous injection, parallel study designed to compare the PK of HLX14 and EU-sourced Prolia® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 2 drugs. Part II of the study： This is a randomised, double-blind, four-arm, single-dose, subcutaneous injection, parallel-controlled study to evaluate the PK, PD, safety, tolerability, and immunogenicity between-group following a single subcutaneous injection of HLX14 or US, EU, CN-sourced Prolia®.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	HLX14	healthy volunteers receive HLX14 (60mg) once
DRUG	EU-Prolia®	healthy volunteers receive EU-Prolia® (60mg) once
DRUG	US-Prolia®	healthy volunteers receive US-Prolia® (60mg) once
DRUG	CN-Prolia®	healthy volunteers receive CN-Prolia® (60mg) once

Timeline

• Start date: 2020-11-03
• Primary completion: 2023-09-12
• Completion: 2023-09-12
• First posted: 2020-09-01
• Last updated: 2025-01-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study