NCT06126718

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: BioRay Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Psoriasis

Interventions

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

Timeline

• Start date: 2024-02-21
• Primary completion: 2024-08-19
• Completion: 2024-08-19
• First posted: 2023-11-13
• Last updated: 2025-06-24

Locations

1 site across 1 country: China