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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 Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 50 Years
Gender Male
More Inclusion & Exclusion 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.
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  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06126718
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 BioRay Pharmaceutical Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Yu Cao, Doctor
Principal Investigator Affiliation The Affiliated Hospital of Qingdao University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Arms & Interventions

Arms

Experimental: BR201

Active Comparator: Cosentyx (Secukinumab)

Interventions

Drug: - BR201

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

Drug: - Cosentyx（Secukinumab ）

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Yu Cao, Doctor

caoyu1767@126.com

+86-18661809090

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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