NCT04534582View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL

Enrollment

252

Participants

Timeline

Start Date

November 3, 2020

Primary Completion Date

September 12, 2023

Study Completion Date

September 12, 2023

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

Trial Locations (1)

200040

Huashan Hospital，Fudan University, Shanghai

All Listed Sponsors

lead

Shanghai Henlius Biotech

INDUSTRY

NCT04534582 - Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects | Biotech Hunter | Biotech Hunter