A Randomised, Double-Blind, Placebo-Controlled Phase I Study to Assess the Tolerability, Safety, Pharmacokinetic, and Pharmacodynamic Properties of AZD6482, Alone and co-Administered With ASA, After Single Ascending Intravenous Doses to Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 49
- 主要终点
- General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables
研究概览
简要总结
AZD6482 is a new drug substance aiming to prevent blood clots which may arise in atherosclerotic blood vessels and cause myocardial infarction or stroke. This is the first study with AZD6482 in humans. The primary aim for this study is to evaluate the safety and tolerability of AZD6482 in healthy human volunteers. How the substance is metabolised and eliminated from the body will also be studied. This will be done by comparing the effect of single ascending doses of AZD6482 to placebo (inactive substance).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
- •Provision of written informed consent
排除标准
- •Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
- •Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until administration of investigational product or clinically significant abnormalities in clinical chemistry, haematology, faeces, urinalysis or supine BP or pulse
- •Known impaired glucose intolerance or known or suspected Gilbert´s syndrome
研究组 & 干预措施
1
干预措施: AZD6482 (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables
时间窗: Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.
次要结局
- Capillary Bleeding Time, Insulin and glucose homeostasis (HoMa-Index)(Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.)
- Pharmacokinetics and inhibition of platelet aggregation(Prior to dose and repeatedly during 24 hrs after dose.)