Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects

Sponsor
BioRay Pharmaceutical Co., Ltd.
Study ID
NCT06126718
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • BR201 — DRUG
    One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given
  • Cosentyx（Secukinumab ） — DRUG
    One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given

Study Details

This is a randomized, open-label, controlled Phase I study of BR201 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of BR201 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose.

Key Dates

Start date
Feb 21, 2024
Status verified
Jun 2025
Primary completion
Aug 19, 2024
Completion
Aug 19, 2024

Study Design

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

Arms

  • Experimental: BR201
  • Active Comparator: Cosentyx (Secukinumab)

Primary Outcome Measure

AUC0-inf [ Time Frame: Till Day112 ]

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