Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects
- Registration Number
- NCT06126718
- Lead Sponsor
- BioRay Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 88
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BR201 BR201 - Cosentyx (Secukinumab) Cosentyx（Secukinumab ） -
- Primary Outcome Measures
Name Time Method Cmax Till Day112 The max concentration after drug given
AUC0-inf Till Day112 Area under the cure from 0 to infinite
- Secondary Outcome Measures
Name Time Method T1/2 Till Day112 Half life
Tmax Till Day112 The time for drug enlarge to max concentration
Vz/F Till Day112 Apparent volume of distribution
CL/F Till Day112 Clearance
AUC0-t Till Day112 Area under the cure from 0 to some time
Immunogenicity Till Day112 ADA
Evaluation about injection site reactions 0 mins, 0.5 hours, 24 hours and 72 hours after drug given Evaluation about injection site reactions
ECG Till Day112 ECG
AE Till Day112 Advance event
Incidence of laboratory abnormalities Till Day112 To be summarized using descriptive statistics