Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects

Sponsor
Shanghai Henlius Biotech
Study ID
NCT03357939
Phase
PHASE1
Status
Completed

Conditions

  • Immune System Disorder

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • HLX03 — DRUG
    A single dose of 40 mg HLX03 in 0.8 mL in subcutaneous injection.
  • adalimumab — DRUG
    A single dose of 40 mg Humira in 0.8 mL in a pre-filled syringe

Study Details

This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spourced,40 mg/0.8 mL injection with a single-use prefilled syringe). This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity evaluation of drug levels following administration of HLX03 and the licensed adalimumab products.

Key Dates

Start date
Jan 12, 2017
Status verified
May 2022
Primary completion
Sep 15, 2018
Completion
Sep 15, 2018

Study Design

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

Arms

  • Experimental: HLX03
    There are about 68 subjects in this group will receive a single dose of 40 mg of HLX03 in 0.8 mL in subcutaneous injection.
  • Active Comparator: Humira
    There are about 68 subjects in this group will receive a single dose of 40 mg of Humira in a pre-filled syringe in subcutaneous injection.

Primary Outcome Measure

Maximum Concentration（Cmax） of Adalimumab After Single SC Injection of HLX03/Humira [ Time Frame: 71 days post-dose ]

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