A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects

Sponsor
Shanghai Henlius Biotech
Study ID
NCT06159101
Phase
PHASE1
Status
Unknown

Conditions

  • Healthy Male Volunteers

Eligibility Criteria

Sex
MALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • HLX13 — DRUG
    A single dose (0.3 mg/kg) of HLX13 via intravenous infusion.
  • CN-sourced ipilimumab — DRUG
    A single dose (0.3 mg/kg) of CN-sourced ipilimumab via intravenous infusion.
  • EU-sourced ipilimumab group — DRUG
    A single dose (0.3 mg/kg) of EU-sourced ipilimumab via intravenous infusion.
  • US-sourced ipilimumab group — DRUG
    A single dose (0.3 mg/kg) of US-sourced ipilimumab via intravenous infusion.

Study Details

Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX13 with YERVOY® Injection in Healthy Chinese Male Subjects

Key Dates

Start date
Nov 28, 2023
Status verified
Nov 2023
Primary completion
May 28, 2024
Completion
May 28, 2024

Study Design

Enrollment
304 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX13 group
    Recombinant anti-CTLA-4 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.
  • Active Comparator: CN-sourced ipilimumab group
    CN-sourced ipilimumab
  • Active Comparator: EU-sourced ipilimumab group
    EU-sourced ipilimumab
  • Active Comparator: US-sourced ipilimumab group
    US-sourced ipilimumab

Primary Outcome Measure

Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) [ Time Frame: Up to Day 90 ]

Central Contacts

  • Hu Wei
    +86-0551-65997165

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