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

Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Study ID
NCT07254325
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Dec 15, 2025
Status verified
May 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

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

Arms

  • Experimental: Biosimilar Product
    new process CMAB015（Secukinumab ） 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 ]

Related Studies