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CompletedNCT06126718Updated Jun 24, 2025

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

A Phase 1 interventional study of BR201 and Cosentyx(Secukinumab ) in Psoriasis, sponsored by BioRay Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by BioRay Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

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.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 88 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

BioRay Pharmaceutical Co., Ltd. is the lead sponsor of 17 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    BR201

    Drug: BR201

  • Active comparator
    Cosentyx (Secukinumab)

    Drug: Cosentyx(Secukinumab )

Interventions

  • DrugBR201

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

  • DrugCosentyx(Secukinumab )

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

06

What researchers measure

Primary outcomes

  1. AUC0-inf

    Area under the cure from 0 to infinite

    Time frame: Till Day112

  2. Cmax

    The max concentration after drug given

    Time frame: Till Day112

Secondary outcomes

  1. AUC0-t

    Area under the cure from 0 to some time

    Time frame: Till Day112

  2. Tmax

    The time for drug enlarge to max concentration

    Time frame: Till Day112

  3. T1/2

    Half life

    Time frame: Till Day112

  4. Vz/F

    Apparent volume of distribution

    Time frame: Till Day112

  5. CL/F

    Clearance

    Time frame: Till Day112

  6. Immunogenicity

    ADA

    Time frame: Till Day112

  7. AE

    Advance event

    Time frame: Till Day112

  8. Evaluation about injection site reactions

    Evaluation about injection site reactions

    Time frame: 0 mins, 0.5 hours, 24 hours and 72 hours after drug given

  9. ECG

    ECG

    Time frame: Till Day112

  10. Incidence of laboratory abnormalities

    To be summarized using descriptive statistics

    Time frame: Till Day112

07

Study locations

1 site
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06126718
Lead sponsor
BioRay Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 13, 2023
Start date
Feb 21, 2024
Primary completion
Aug 19, 2024
Completion
Aug 19, 2024
Last update
Jun 24, 2025

Study contacts

Yu Cao, Doctor
principal investigator · The Affiliated Hospital of Qingdao University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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