Double-blind, Randomised, Placebo-controlled, Multicentre, Phase IIa Study to Investigate the Effect of PC-mAb on Arterial Inflammation in Subjects With Elevated Lipoprotein a
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Monocyte function
研究概览
简要总结
Inflammation and abnormal amount of lipids in the blood are key factors for the development and progression of atherosclerosis (thickening of the artery wall) and cardiovascular disease. Lipoprotein (a) is a pro-inflammatory plasma lipoprotein that is believed to be a risk factor for cardiovascular diseases. Vascular inflammation generates a range of effects, including endothelial dysfunction and migration of white blood cells into the vessel wall, which results in increased risk of cardiovascular events.
This study is designed to assess the effects of multiple monthly intravenous infusions with the fully human antibody called PC-mAb, in subjects with elevated lipoprotein (a).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PC-mAb
Phosphorylcholine human monoclonal antibody, i.v. infusions
干预措施: PC-mAb (Drug)
Placebo
Placebo to PC-mAb, i.v. infusions
干预措施: Placebo (Drug)
结局指标
主要结局
Monocyte function
时间窗: From baseline (Day 1) to visit 11 (Day 85)
Change in transendothelial migration (TEM) in monocytes isolated from treated subjects
次要结局
- Arterial inflammation(From baseline (Day 1) to visit 11 (Day 85))
- Arterial stiffness(From baseline (Day 1) to visit 11 (Day 85))
- Adverse events (AEs)/serious AEs (SAEs)(From baseline (Day 1) to visit 11 (Day 85))
- Vital signs, height(At screening (Day -63 to -1))
- Vital signs, body weight(At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143))
- Vital signs, blood pressure(At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143))
- Vital signs, hear rate(At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143))
- Vital signs, body temperature(At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143))
- Physical examination including review of all organ systems(At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143))
- Electrocardiogram (ECG), PR (PQ)(At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143))
- ECG, QRS(At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143))
- ECG, QT(At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143))
- ECG, QTcF(At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143))