A Randomized, Double-blinded, Single-dose, 2-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2506 Injection vs Simponi in Healthy Chinese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Pharmacokinetics Endpoint：AUC0-t
研究概览
简要总结
It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi® (EU-licensed ).
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Golimumab, thus to evaluate the change and similarity of the pharmacokinetics of the two study drugs.
The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
详细描述
It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi® (EU-licensed ).
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Golimumab, thus to evaluate the change and similarity of the pharmacokinetics of the two study drugs.
The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy male subjects aged18 and 50 years inclusive; BMI between 18 and 28 kg/m2 and body weight between 50 and 80 kg.
- •Physical examinations and vital signs are normal or abnormal without clinical significance.
- •Abdominal color Doppler ultrasound, laboratory tests, etc. are normal or abnormal without clinical significance.
排除标准
- •Any current or history of severe allergic reaction to foods or drugs and History of allergy to study products.
- •Having severe injuries or surgery or fractures within 4 weeks before enrollment,or to receive surgery during the study.
- •Having clinically significantclinical history abnormalities or other clinically indicated diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, mental or cardiovascular diseases).
- •Having malignant tumor (excluding basal cell carcinoma who has undergone resection).
- •Having clinically significant chronic or acute infections at screening/incorporation; or active infections,Includes acute and chronic infections as well as local infections (bacteria, viruses, parasites, fungi or other opportunities) Sexually infected pathogen).
- •Having a history of tuberculosis or latent tuberculosis or clinical manifestations suspected of being tuberculosis(including But not limited to tuberculosis).
- •Having been exposed to tuberculosis or/and suspected tuberculosis symptoms and/or signs within 3 months before screening.
- •Having used simponi,or any anti-tumor necrosis factor (TNF-α) biologic preparation or any biological products within 6 months before enrollment or monoclonal antibodies within a month.
- •Having used drugs within 30 days before enrollment (including but not limited to prescription drugs, Chinese medicine, non-prescription drugs).
- •Having vaccinated active / attenuated vaccine within 12 weeks before screening or planned to vaccinate active /attenuated vaccine the during the study.
- •Having a history of hypertension or systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ at screening/inclusion90 mmHg, and it is judged abnormalities with clinical significance.
- •Electrocardiogram (ECG) examination abnormalities with clinical significance;
- •Having positive detection of golimumab anti-drug antibody (ADA) during screening.
- •Chest orthotopic examination abnormalities with clinical significance.
- •Tuberculosis enzyme-linked immunospot assay (T-SPOT. TB) positive test,
- •Having any alcoholic products within 24 hours prior to the use of the study drug.
- •A drug abuse test positive or a history of drug abuse over the past five years.
结局指标
主要结局
Pharmacokinetics Endpoint：AUC0-t
时间窗: 0-71days
Pharmacokinetics Endpoint：AUC0-t
Pharmacokinetics Endpoint：Cmax
时间窗: 0-71days
Pharmacokinetics Endpoint：Cmax
次要结局
- Pharmacokinetics Endpoint：AUC0-inf(0-71days)