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

NCT05679258 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-06-28

No results posted yet for this study

Summary

Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX15 with Daratumumab Injection in Healthy Chinese Male Subjects

Conditions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-03-16
Completion
2024-06-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases
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 NCT05679258 on ClinicalTrials.gov