NCT05679258View on ClinicalTrials.gov

A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

January 31, 2023

Primary Completion Date

March 16, 2024

Study Completion Date

June 28, 2024

Conditions
Multiple Myeloma
Interventions
DRUG

HLX15

A single dose (8 mg/kg) of HLX15 via intravenous infusion.

DRUG

US-sourced DARZALEX®

A single dose (8 mg/kg) of US-sourced DARZALEX® via intravenous infusion.

DRUG

CN-sourced DARZALEX®

A single dose (8 mg/kg) of CN-sourced DARZALEX® via intravenous infusion.

DRUG

EU-sourced DARZALEX®

A single dose (8 mg/kg) of EU-sourced DARZALEX® via intravenous infusion.

Trial Locations (2)

100730

Beijing Hospital, Beijing

211112

Sir Run Run Hospital, Nanjing Medical University, Nanjing

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY