A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants Under Fasting Conditions

Sponsor
Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
Study ID
NCT07147257
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • CHS-1420 — BIOLOGICAL
    Dose of 40 mg will be subcutaneously administered to participants in
  • HUMIRA® — BIOLOGICAL
    Dose of 40 mg will be subcutaneously administered to participants in

Study Details

A Single-Center, Randomized, Single-Blind, Single-Dose, Parallel-Group Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants under Fasting Conditions

Key Dates

Start date
Feb 12, 2025
Status verified
Aug 2025
Primary completion
May 6, 2025
Completion
May 29, 2025

Study Design

Enrollment
238 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: CHS-1420
  • Active Comparator: HUMIRA®

Primary Outcome Measure

Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞) [ Time Frame: 0 to 1536 hours post-dose ]

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