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

Sponsor
Shanghai Henlius Biotech
Study ID
NCT05679258
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • HLX15 — DRUG
    A single dose (8 mg/kg) of HLX15 via intravenous infusion.
  • US-sourced DARZALEX® — DRUG
    A single dose (8 mg/kg) of US-sourced DARZALEX® via intravenous infusion.
  • CN-sourced DARZALEX® — DRUG
    A single dose (8 mg/kg) of CN-sourced DARZALEX® via intravenous infusion.
  • EU-sourced DARZALEX® — DRUG
    A single dose (8 mg/kg) of EU-sourced DARZALEX® via intravenous infusion.

Study Details

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

Key Dates

Start date
Jan 31, 2023
Status verified
Jun 2024
Primary completion
Mar 16, 2024
Completion
Jun 28, 2024

Study Design

Enrollment
172 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX15 group
    Recombinant anti-CD38 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.
  • Active Comparator: US-sourced DARZALEX® group
    Daratumumab injection
  • Active Comparator: CN-sourced DARZALEX® group
    Daratumumab injection
  • Active Comparator: EU-sourced DARZALEX® group
    Daratumumab injection

Primary Outcome Measure

Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf). [ Time Frame: Up to Day 91 ]

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