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Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects - Trial NCT06126718

Access comprehensive clinical trial information for NCT06126718 through Pure Global AI's free database. This Phase 1 trial is sponsored by BioRay Pharmaceutical Co., Ltd. and is currently Not yet recruiting. The study focuses on Psoriasis. Target enrollment is 88 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06126718
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06126718
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Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects

Study Focus

Psoriasis

BR201

Interventional

drug

Sponsor & Location

BioRay Pharmaceutical Co., Ltd.

Timeline & Enrollment

Phase 1

Nov 01, 2023

Aug 01, 2024

88 participants

Primary Outcome

AUC0-inf,Cmax

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๏ผˆSecukinumab ๏ผ‰ in healthy male subjects after a single
 dose.

ICD-10 Classifications

Psoriasis
Other psoriasis
Psoriasis, unspecified
Arthropathic psoriasis
Psoriasis vulgaris

Data Source

ClinicalTrials.gov

NCT06126718

Non-Device Trial