Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers

Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Study ID
NCT05734482
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Secukinumab — BIOLOGICAL
    for subcutaneous injection only

Study Details

This is a randomized, double-blinded, controlled Phase I study of CMAB015 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB015 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose.

Key Dates

Start date
Feb 15, 2023
Status verified
Apr 2024
Primary completion
Jul 3, 2023
Completion
Jul 3, 2023

Study Design

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

Arms

  • Experimental: Biosimilar Product
    CMAB015 150 mg Subcutaneous injection in upper arm
  • Active Comparator: Reference Product
    Cosentyx（Secukinumab ） 150 mg Subcutaneous injection in upper arm

Primary Outcome Measure

Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time [ Time Frame: up to 2688 hours ]

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