Clinical trial NCT06126718: Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects
Official title: Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: BioRay Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: AUC0-inf
timeFrame: Till Day112
measure: Cmax
timeFrame: Till Day112
Secondary outcomes:
measure: AUC0-t
timeFrame: Till Day112
measure: Tmax
timeFrame: Till Day112
measure: T1/2
timeFrame: Till Day112
measure: Vz/F
timeFrame: Till Day112
measure: CL/F
timeFrame: Till Day112
measure: Immunogenicity
timeFrame: Till Day112
measure: AE
timeFrame: Till Day112
measure: Evaluation about injection site reactions
timeFrame: 0 mins, 0.5 hours, 24 hours and 72 hours after drug given
measure: ECG
timeFrame: Till Day112
measure: Incidence of laboratory abnormalities
timeFrame: Till Day112
Other outcomes:
Locations:
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yu Cao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: