A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics (PopPK) Profile of ABP-745 in Patients With Atherosclerosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 37
- 主要终点
- Change from the baseline in percent atheroma volume (PAV)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the preliminary efficacy, safety, and PopPK profile of ABP-745 in patients with ASCVD. Efficacy of ABP-745 in reducing atherosclerotic plaque compared with placebo will be evaluated in participants with ASCVD. The primary efficacy measurement will be assessed at 52W of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unless otherwise specified, subjects must meet all of the following criteria at screening:
- •Diagnosed with coronary at herosclerosis, and coronary angiography.
- •Male or female at 18-75 years of age (inclusive).
- •Weight ≥40 kg.
- •Currently using any oral lipid-lowering therapy.
- •Able to understand and willing to sign an ICF and comply with study requirements.
- •A woman or man of childbearing potential agreeing to use medically approved contraceptive methods from the screening until 3 months after the last study dose.
排除标准
- •Unless otherwise specified, subjects are excluded from the study if any of the following criteria is met:
- •History of stroke within the past 6 months.
- •Uncontrolled arrhythmia within 3 months prior to screening.
- •Evidence of any active or suspected cancer within 3 years prior to the screening.
- •Having undergone any major surgery within 3 months prior to the screening or planning to undergo any major surgery during the study.
- •Presence or suspicion of ongoing of any serious infection.
- •Human immunodeficiency virus (HIV) infection.
研究组 & 干预措施
Placebo group
Existing lipid-lowering maintenance medications unchanged.
干预措施: Placebo (Drug)
ABP-745 Dose A
Existing lipid-lowering maintenance medications unchanged.
干预措施: ABP-745 Dose A (Drug)
ABP-745 Dose B
Existing lipid-lowering maintenance medications unchanged.
干预措施: ABP-745 Dose B (Drug)
ABP-745 Dose C
Existing lipid-lowering maintenance medications unchanged.
干预措施: ABP-745 Dose C (Drug)
结局指标
主要结局
Change from the baseline in percent atheroma volume (PAV)
时间窗: 52 weeks after treatment
次要结局
- Change from the baseline in percent atheroma volume (PAV)(24 weeks after treatment)
- Incidence of treatment-emergent adverse events (Safety and Tolerability) TEAEs and SAEs, and clinically significant changes in physical examination, vital signs, safety laboratory tests, and 12-lead ECG.(up to 14 days post the last dose of study drug)