NCT06126718已完成1 期
Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
BR201
Experimental
干预措施: BR201 (Drug)
Cosentyx (Secukinumab)
Active Comparator
干预措施: Cosentyx（Secukinumab ） (Drug)
结局指标
主要结局
Cmax
时间窗: Till Day112
The max concentration after drug given
AUC0-inf
时间窗: Till Day112
Area under the cure from 0 to infinite
次要结局
- Tmax(Till Day112)
- T1/2(Till Day112)
- Vz/F(Till Day112)
- CL/F(Till Day112)
- AUC0-t(Till Day112)
- Immunogenicity(Till Day112)
- Evaluation about injection site reactions(0 mins, 0.5 hours, 24 hours and 72 hours after drug given)
- ECG(Till Day112)
- AE(Till Day112)
- Incidence of laboratory abnormalities(Till Day112)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult ParticipantsHepatitis BNCT06058390GlaxoSmithKline160
尚未招募
1 期
Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid ArthritisRheumatoid ArthritisNCT03828344Baylx Inc.16
撤回
2 期
Standard Therapy Using Tacrolimus, Mycophenolate Mofetil and Prednisone For Chronic Lung Transplant Rejection (BOS)Disorder Related to Lung TransplantationChronic Rejection of Lung TransplantDecreased Immunologic ActivityNCT04415476University of Maryland, Baltimore
已完成
1 期
Safety, Immunogenicity and Efficacy of R21 Matrix-M in 5-17 Month Old Children in Nanoro, Burkina FasoMalaria,FalciparumNCT03896724University of Oxford450
已完成
1 期
Study in Blood Stage Malaria Infection After DVI of Cryopreserved P. Falciparum (NF54 Strain) SporozoitesMalaria,FalciparumParasitemiaProtozoan InfectionsParasitic DiseaseNCT04310085Medicines for Malaria Venture16