A Phase II Randomized, Placebo-Controlled, Single-Blind, Multi-Center Dose-Escalation Study to Evaluate Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Administration of INO-1001 in Subjects With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 27
- 主要终点
- The safety of INO-1001 will be measured by evaluation of symptoms, vital signs, physical examination, laboratory data, electrocardiograms, etc.
研究概览
简要总结
The primary purpose of this study is to assess the safety of INO-1001 in subjects who have experienced a heart attack and are to be treated with coronary angioplasty.
详细描述
Currently, heart attacks may be treated with clot-dissolving medicines, coronary angioplasty, or a combination of both. Unblocking of blood flow to the heart following coronary angioplasty can cause side effects such as heart tissue and blood vessel damage, abnormal heart rhythms and death of heart muscle cells.
In animal studies, the PARP enzyme has been shown to be involved in damaging heart muscle after the sudden unblocking of coronary arteries. INO-1001 blocks the PARP enzyme, and so it may reduce heart damage in humans who have had their coronary arteries unblocked after a heart attack.
A total of 40 patients will be selected and randomly assigned to either INO-1001 or placebo (sugar water). One dose only of the drug will be given prior to coronary angioplasty. Patients will be followed until 30 days after surgery.
The following information will be gathered: vital signs, symptoms, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts.
The information provided in this listing is disclosed solely to comply with regulatory requirements. The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with acute myocardial infarction (as defined in protocol) with onset within 24 hours prior to randomization.
- •Scheduled for primary percutaneous coronary intervention within 3 hours of presentation at a hospital participating in this study.
- •Males and non-pregnant, non-lactating females.
排除标准
- •Subjects will be required to undergo a full medical review in order to exclude serious medical, or psychological illness prior to inclusion.
- •History of a hypersensitivity reaction to more than three drugs or mannitol.
- •Participation in any investigational study within 30 days of randomization
- •Treatment with certain restricted medications within a specified time prior to participation in the study.
结局指标
主要结局
The safety of INO-1001 will be measured by evaluation of symptoms, vital signs, physical examination, laboratory data, electrocardiograms, etc.
次要结局
- The effect of INO-1001 on heart muscle damage will be evaluated by blood tests. Other blood tests will measure how INO-1001 is absorbed and removed by the body after exposure to different doses.