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

NCT04534582 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2025-01-20

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Jing Zhang, Doctor · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
28 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2023-09-12
Completion
2023-09-12
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534582 on ClinicalTrials.gov