First Assessment of the Glycoprotein Ib-IV-V Complex Antagonist Anfibatide in Healthy Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 主要终点
- Safety endpoints
研究概览
简要总结
In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and low bleeding potential in healthy human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, aged 18-28 years, male and female were included, age difference less than 10 years;
- •Body weight: with body mass index (BMI) between 19-24, difference less than 10kg in the same group, BMI=body weight(kg)/height2;
- •Past medical history: no history of heart, liver, kidney, digestive tract, nervous system and metabolic disorder, or ulcer, significant hemorrhage, without the history of drug allergy and postural hypotension;
- •Medical examinations: with normal results in overall examinations (including heart rate, blood pressure, auscultation of heart and lung, palpation of liver and spleen, hepatic and renal function, hematology, coagulation function, urine analysis, stool analysis and occult blood test, electrocardiogram);
- •Have not received any medications within 2 weeks before the study;
- •Willing to participate in the study and give a signed informed consent form after understanding the study procedures and potential adverse reactions of the study product.
排除标准
- •History of HBV or HCV infection;
- •Addicted to smoking or alcohol;
- •Women during pregnancy, lactation or menstrual period;
- •Past history of hemoptysis, bloody stool, bleeding spots in the skin and mucous membrane, or hemorrhagic tendency (find themselves prone to bleeding in gums, nose, skin and mucous membrane, or hemoptysis);
- •History of active bleeding (such as peptic ulcer, hemorrhoids, active tuberculosis, subacute bacterial endocarditis, etc);
- •Blood platelet count less than 150×109;
- •Trauma history (e.g., craniocerebral trauma) recently;
- •Past history of unexplained syncope or convulsion;
- •History of organic or psychogenic disease or the disabled;
- •Persons who were unlikely to participate in the study (such as the infirm) in the investigator's opinion;
- •Have donated blood or experienced blood collection in other trials within 3 months.
研究组 & 干预措施
Single dose gourp 1
Anfibatide injection at the concentration of 0.33μg/60kg in healthy volunteers
干预措施: Anfibatide (Drug)
Single dose group 2
Anfibatide injection at the concentration of 0.66μg/60kg in healthy volunteers
干预措施: Anfibatide (Drug)
Single dose groups 3
Anfibatide injection at the concentration of1.0μg/60kg in healthy volunteers
干预措施: Anfibatide (Drug)
Single dose group 4
Anfibatide injection at the concentration of 1.5μg/60kg in healthy volunteers
干预措施: Anfibatide (Drug)
Single dose group 5
Anfibatide injection at the concentration of 2.0μg/60kg in healthy volunteers
干预措施: Anfibatide (Drug)
Single dose group 6
Anfibatide injection at the concentration of 3.0μg/60kg in healthy volunteers
干预措施: Anfibatide (Drug)
Single dose group 7
Anfibatide injection at the concentration of 4.0μg/60kg in healthy volunteers
干预措施: Anfibatide (Drug)
Single dose group 8
Anfibatide injection at the concentration of 5.0μg/60kg in healthy volunteers
干预措施: Anfibatide (Drug)
Multiple dose group 9
Give intravenous injection of 3μg as the first dose and after 1.5 hours, infusion of the study product 0.12μg/h for 24 hours
干预措施: Anfibatide (Drug)
Multiple dose group 10
Give intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours.
干预措施: Anfibatide (Drug)
Multiple dose group 11
Give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours
干预措施: Anfibatide (Drug)
结局指标
主要结局
Safety endpoints
时间窗: 24 Hours
To investigate the number of adverse events in patients with single or multiple intravenous injection/infusion of Antiplatelet
次要结局
- Area Under Curve (AUC)(Predose, 0,1,2,3,4,6,8,12,24,48,72,96 Hours)
研究者
Vivian Fung
Ph.D
Lee's Pharmaceutical Limited