drugset / Trial / NCT06126718

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

NCT06126718

Phase 1 Completed 88 enrolled BioRay Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject BR201 Unknown Subcutaneous
Comparator Secukinumab Monoclonal antibody

Indications