NCT01499420已完成2 期
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
适应症
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
- 12
- 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
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)
研究者
研究点 (12)
Loading locations...
相似试验
终止
2 期
Eliminate Coronary Artery DiseaseCoronary Artery DiseaseNCT02245087University Health Network, Toronto28
已完成
不适用
Lipid Profile in Acute Coronary SyndromeAcute Coronary SyndromeNCT05126043Sohag University200
已完成
2 期
The Effects of RVX000222 on Glucose Metabolism in Individuals With Pre-diabetesDiabetesNCT01728467Resverlogix Corp20
已完成
3 期
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and TaiwanHypercholesterolemiaNCT02289963Sanofi199
已完成
3 期
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)HypercholesterolemiaNCT02023879Sanofi233