A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of CSL112 in Patients With Stable Atherothrombotic Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CSL Limited
- 入组人数
- 45
- 试验地点
- 11
- 主要终点
- Safety
研究概览
简要总结
Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years to 80 years.
- •Subjects must have documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization.
- •Subjects on a stable medication regimen.
- •Body weight 50 kg or greater at screening.
排除标准
- •Moderate/severe heart failure or renal impairment.
- •Uncontrolled hyperglycemia in subjects with type 1 or type 2 diabetes.
- •Receipt of the combination of omeprazole and clopidogrel within 1 month of randomization.
- •Subjects whose medical history, condition or medication regimen may interfere with the evaluation of the safety and tolerability of CSL112 (for example significantly altered electrocardiogram (ECG) waveform, hepatobiliary disease, malignancy, thrombocytopenia, etc.)
- •Known hypersensitivity to the product components
研究组 & 干预措施
Placebo
干预措施: Placebo (Biological)
CSL112
干预措施: CSL112 (reconstituted high density lipoprotein) (Biological)
结局指标
主要结局
Safety
时间窗: 14 days
The frequency of study product-related adverse events
Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
时间窗: 14 days
Number of subjects with clinically significant elevation of ALT or AST
次要结局
- Pharmacokinetic profile of apolipoprotein A-I (apoA-I)(9 days)
- Plasma apoA-I area under the curve (AUC)(9 days)
- Plasma apoA-I Cmax(9 days)
- Plasma apoA-I Tmax(9 days)