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

NCT06126718 | Completed Phase 1

• 1 other identifier: BR201-101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AUC0-inf

  Area under the cure from 0 to infinite

  Till Day112

• Cmax

  The max concentration after drug given

  Till Day112

Secondary Outcomes (10)

• AUC0-t

  Till Day112

• Tmax

  Till Day112

• T1/2

  Till Day112

• Vz/F

  Till Day112

• CL/F

  Till Day112

Study Arms (2)

BR201

EXPERIMENTAL

Drug: BR201

Cosentyx (Secukinumab)

ACTIVE COMPARATOR

Drug: Cosentyx（Secukinumab ）

Interventions

BR201 DRUG

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

BR201

Cosentyx（Secukinumab ） DRUG

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

Cosentyx (Secukinumab)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.;

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yu Cao, Doctor

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 13, 2023
• Study Start: February 21, 2024
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (1)