Phase I Clinical Trial of the Tolerance and Pharmacokinetics of Anfibatide in Health Volunteer
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bleeding events
研究概览
简要总结
This is a phase 1, dose-escalation, and multidose study, aiming to investigate the tolerability, safety and pharmacokinetics of Anfibatate in healthy subjects. The study is divided into 2 intravenous single groups and 3 continuous administration groups. The dose of Anfibatate from 5 IU/60kg to 7 IU/60kg in intravenous single groups. The dose of Anfibatate from 0.002 IU/kg/h, 0.004 IU/kg/h to 0.008 IU/kg/h in continuous administration groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy subjects between the ages of 18 to 40 years（including）.
- •The body mass index（BMI）， in the range of 19 ~ 24 (including).
- •Medical history without heart, liver, kidney, digestive tract, nervous system, metabolic, ulcer, obvious bleeding, and history of drug allergy or postural hypotension.
- •According to the medical history, physical examination, vital signs, chest radiograph, 12-lead ECG, coagulation routine, stool routine and occult blood test, as well as the laboratory results of blood and urine, the subjects are healthy.
- •The subjects do not take any medicine in the past two weeks.
- •Willingness to participate the study and sign the written Informed Consent Form.
- •Non-lactating women willingness to use adequate contraceptive measures (including abstinence, intrauterine device, diaphragm and spermicide) during the study (screening period to 1 week after administration). Men are willing to use approved methods of contraception (including condoms and spermicides or oral, implanted or injectable contraceptives by their partners, intrauterine device, diaphragms and spermicides). Subjects do not plan to donate sperm or eggs within two weeks after drug administration.
排除标准
- •Abnormal with the safety evaluation is considered to be clinical significance in screening period as judged by the researcher.
- •Subjects with history of hepatitis B virus, hepatitis C virus, human immunodeficiency virus and syphilis virus infection;
- •Excessive smoking (>5 cigarettes/day) or do not interrupt smoke during the study.
- •Intake of more than 25g of alcohol per day (equivalent to 750 mL of beer or 250 mL of wine, or 75 mL of white wine of 38 °, or 50 mL of white wine of ≥40 ° ). Subject who are positive for alcohol breath test or cannot stop drinking during the study.
- •Women with pregnant, lactating or menstruating.
- •History of previous hemoptysis, blood stool, skin mucosal bleeding points, etc., or bleeding tendency (patients with gingival, nasal, skin, mucosal bleeding, hemoptysis).
- •History of active bleeding (peptic ulcer, hemorrhoids, active tuberculosis, subacute bacterial endocarditis, etc.).
- •The examination show arteriovenous malformation, hemangioma and other vascular abnormalities.
- •The examination show that there is hemorrhage in the fundus.
- •The platelet count is less than 150×109/L.
- •History of trauma (craniocerebral trauma, etc.) within 1 year.
- •History of unexplained syncope or convulsions.
- •History of autoimmune diseases, such as systemic lupus erythematosus.
- •History of organic or mental illnesses or disabilities.
- •According to the judgment by the researchers, subjects with low possibility of enrollment (such as weak body, etc.).
- •Donation of blood in the last 3 months or participation in other clinical trials in the last 3 months.
- •Previously recruited into other clinical studies of the product.
- •Mental, psychological, or language disorders that prevent understanding or cooperation.
- •Unwilling or unable to comply with the study schedule or procedure.
- •Unfit to participate in the study for any other reason.
研究组 & 干预措施
Anfibatide 5 IU/60kg
Ten subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes.
干预措施: Anfibatide 5 IU/60kg (Drug)
Anfibatide 5 IU/60kg+0.002 IU/kg/h
Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours.
干预措施: Anfibatide 5 IU/60kg +0.002 IU/kg/h (Drug)
Anfibatide 5 IU/60kg+0.004 IU/kg/h
Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours.
干预措施: Anfibatide 5 IU/60kg +0.004 IU/kg/h (Drug)
Anfibatide 5 IU/60kg+0.008 IU/kg/h
Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours.
干预措施: Anfibatide 5 IU/60kg +0.008 IU/kg/h (Drug)
Anfibatide 7 IU/60kg
Ten subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes.
干预措施: Anfibatide 7 IU/60kg (Drug)
Anfibatide 7 IU/60kg+0.002 IU/kg/h
Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours.
干预措施: Anfibatide 7 IU/60kg +0.002 IU/kg/h (Drug)
Anfibatide 7 IU/60kg+0.004 IU/kg/h
Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours.
干预措施: Anfibatide 7 IU/60kg +0.004 IU/kg/h (Drug)
Anfibatide 7 IU/60kg+0.008 IU/kg/h
Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours.
干预措施: Anfibatide 7 IU/60kg +0.008 IU/kg/h (Drug)
结局指标
主要结局
Bleeding events
时间窗: 7 days after drug administration
Bleeding events are judged according to Bleeding Academic Research Consortium Definition for Bleeding criteria.
次要结局
- Cmax(7 days after drug administration)
- Tmax(7 days after drug administration)
- AUC(0-t)(7 days after drug administration)
- T1/2(7 days after drug administration)
- AUC(0-∞)(7 days after drug administration)
- Inhibition of platelet aggregation(7 days after drug administration)
- corrected QT interval(7 days after drug administration)