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

NCT06126718 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-06-24

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • BioRay Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yu Cao, Doctor · The Affiliated Hospital of Qingdao University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-21
Primary Completion
2024-08-19
Completion
2024-08-19

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126718 on ClinicalTrials.gov