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

NCT ID: NCT06126718

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2024-08-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BR201

Group Type: EXPERIMENTAL

BR201

Intervention Type: DRUG

One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given

Cosentyx (Secukinumab)

Group Type: ACTIVE_COMPARATOR

Cosentyx（Secukinumab ）

Intervention Type: DRUG

One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given

Interventions

BR201

One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given

Intervention Type: DRUG

Cosentyx（Secukinumab ）

One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Able to understand and sign informed consent form；
• Healthy men 18-50 years of age at time of consent；
• Body weight of ≥50 kg and ≤ 80 kg and BMI ≥19 and ≤ 26 kg/m2.

Exclusion Criteria

• Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, mental or cardiovascular and cerebrovascular diseases) with clinical significance;
• Use of IL-17 or other monoclonal antibodies in the last 6 months;
• Positive for anti-IL-17 antibodies at screening;
• Evidence of tuberculosis infection;
• With active infection at screening or have been hospitalized for a serious infection during the 8 months prior to screening or use of antibiotics within 2 weeks of enrollment;
• Anti-IL-17 antibody active ingredient, excipients or latex allergy;
• With severe bleeding factors that affect venous blood collection or unwilling to undergo venipuncture;
• Use drug treatment (including prescription drugs, over-the-counter drugs, health product etc.) within 14 days before screening;
• Surgery within 2 months prior to screening; or plan to have surgery during the study period;.
• Have received live vaccines within 6 months prior to screening, or have used any vaccines within 4 weeks prior to screening, or plan to be vaccinated during the trial.;
• History of malignant neoplasms；
• Hepatitis B and/or Hepatitis C; or HIV antigen/antibody positive; or Treponema pallidum antibody positive; .
• Blood donation or massive blood loss (> 400 ml) within 3 months or blood loss (> 200 ml) within 1 month before signing the informed consent; or plan to donate blood during the trial;
• Have a history of drug or substance abuse before screening; or positive drug abuse test results on the day of check-in;
• Acute disease occurred or with concomitant medication from the screening to use of the study drug.;
• Have pregnancy plan or sperm donation plan during the whole trial period and within 6 months after the completion of the study;
• Other conditions considered inappropriate to be included in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

BioRay Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu Cao, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Qingdao University

Locations

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Countries

China

Other Identifiers

BR201-101

Identifier Type: -

Identifier Source: org_study_id