An Intravenous, Open-label, Single-dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of rhLCAT in Subjects With Coronary Artery Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Summary of Participants Experience with Safety and Tolerability
研究概览
简要总结
This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501. The dose will be escalated by cohort.
详细描述
After signing informed consent, subjects entered into the trial will be followed for up to 8 weeks which includes: up to 4 weeks screening, entry criteria assessments on Day 0 and single-dose IV infusion on Day 1, and 4 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of stable documented CAD
- •Currently non-smoking males and females ages 30 to 85 years inclusive.
- •o Female subjects of child-bearing potential (neither pregnant nor breast-feeding) must be using adequate birth control during study conduct.
- •Chronic concomitant medications must be stable for at least 2 months prior to screening
- •HDL-C < 50 mg/dL for men and < 55 mg/dL for women
- •Body Mass Index (BMI) of approximately 18 to 35 kg/m^2; and a total body weight >= 50 kg (110 lbs) and <= 110 kg (approximately 242 lbs)
排除标准
- •Myocardial infarction, stroke, or coronary intervention/revascularization procedure within 6 months prior to dosing.
- •Chronic heart failure (> New York Heart Association (NYHA) Functional Classification II).
- •Ventricular tachyarrhythmias.
- •Uncontrolled Type 2 (HbA1c > 8.5%) or Type 1 diabetes mellitus.
- •History of febrile illness within 5 days prior to dosing.
- •History of regular alcohol consumption exceeding 10 drinks per week.
- •12-lead ECG demonstrating QTc > 500 msec at screening.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
研究组 & 干预措施
ACP-501
干预措施: ACP-501 (Drug)
结局指标
主要结局
Summary of Participants Experience with Safety and Tolerability
时间窗: Day 1 to Day 28
Safety and tolerability of a single dose of ACP-501 as determined by adverse event reporting, clinical laboratory results, vital signs, physical examination, and electrocardiograms (ECGs).
次要结局
- Pharmacokinetic profile(Hours 0, 1, 6, 12, 24, 48, 72, 96, 168)
- Change in High-Density Lipoprotein-Cholesterol (HDL-C) value following a single dose(Hours 0, 1, 6, 12, 24, 48, 72, 96, 168)