NCT03083990已完成1 期
Compare IBI305 to Avastin on the Pharmacokinetics, Safety, Tolerance and Immunogenicity of a Single Dose In Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study
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
- 100
- 试验地点
- 1
- 主要终点
- AUC0 - ∞
研究概览
简要总结
To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •To be eligible for the study, patients should fulfill all the following criteria:
- •Fully understand the study purpose, and understand the pharmacological effects and potential adverse reactions of the drug, voluntarily signed written informed consent according to the declaration of Helsinki.
- •Age ≥18 and ≤ 50, healthy male subjects
- •Weigh ≥ 50 kg and ≤ 100 kg， BMI≥ 19 and ≤ 28 kg/m2
- •All the system test result within the normal range, or abnormal test results without clinical significance judged by the investigator.
- •The subjects must agree to use effective contraceptive measures during the study treatment and for 6 months after receiving last does of study drug (e.g. abstinence, sterilization surgery, oral contraceptives, contraception by progesterone injection or subcutaneous)
排除标准
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •Medical history of high blood pressure or abnormal blood pressure at screening/baseline(Double confirmed systolic blood pressure (SBP) >140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg within one day)
- •Proteinuria with clinical significance judged by the investigator (routine urine examination, urine protein 2 + and above) or a history of proteinuria.
- •Any prior VEGF(vascular endothelial growth factor) and VEGFR(Vascular Endothelial Growth Factor Receptor) antibody or protein treatment within one year.
- •Any biological products or a live virus vaccine treatment within 3 months , or any monoclonal antibodies within 12 months before the first dose of study drug.
- •History or evidence of inherited bleeding diathesis or coagulopathy or thrombus.
- •History of digestive tract perforation or digestive tract fistula.
- •Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 2 months prior to randomization or anticipation of need for major surgery during the course of the study or 2 months after last dose of the study drug.
- •Use Rx or OTC drugs or nutritional health products within 5 half-lives or within 2 weeks before the first dose of study drug (According to the longer time).Herbal supplements need to stop at 28 days before the first dose of study drug.
- •Positive hepatitis b surface antigen (HBsAg), hepatitis c virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody or syphilis
- •Known hypersensitivity to Bevacizumab or any excipients
- •Known allergic disease or allergic constitution
- •History of blood donation within 3 months before the first dose of study drug
- •Treatment with any other investigational agent or participation in another clinical trial within 3 months prior to screening
- •History of alcoholism or drug abuse within 12 months prior to screening; Subjects cannot temperance within 72 hours before study drug infusion and during the whole study
- •History of mental illness
- •Anticipated of partner pregnancy during the study.
- •Incompliance to the clinical study protocol during the study.
- •Other conditions that the investigator thinks unsuitable in this study
研究组 & 干预措施
Group A
Experimental
IBI 305 ,3mg/kg, infusion in 90 minutes
干预措施: IBI305(Bevacizumab Biosimilar) (Biological)
Group B
Active Comparator
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes
干预措施: Avastin(Bevacizumab) (Drug)
结局指标
主要结局
AUC0 - ∞
时间窗: 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days
the area under the blood drug concentration time curve form 0 to ∞AUC0 - ∞)
AUC0 - t
时间窗: 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days
the area under the blood drug concentration time curve form 0 to t (AUC0 - t)
次要结局
- Clearance Rate(60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days)
- t1/2(60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days)
- Cmax(60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days)
- Apparent Volume of Distribution(60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days)
研究者
研究点 (1)
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