NCT04826172已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of stable angina (CCS grading I-III) or anginal equivalent for ≥1 month prior to screening
- •Ability to safely abstain from beta blockers for 48 hours prior to echo examinations in the opinion of the Investigator
- •Preserved LV systolic function, defined as LVEF≥50% by any imaging modality
- •Obstructive CAD and recent evidence of stress-induced myocardial ischemia
排除标准
- •Women of childbearing potential or who are currently pregnant or breast-feeding
- •Clinically indicated for coronary revascularization (PCI/CABG) at time of screening or clinically significant LMS or proximal LAD stenosis likely to warrant revascularization during the study period in the opinion of the investigator.
- •Type 1 insulin dependent diabetes mellitus (IDDM)
- •Presence of pacemaker, cardiac resynchronization therapy and/or implantable cardioverter defibrillator
- •Severe or clinically significant valvular heart disease
- •Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability
研究组 & 干预措施
IMB-1018972 200mg
Experimental
干预措施: IMB-1018972 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs
时间窗: Randomization through Week 10 Safety Follow-up
次要结局
- Change in number of ischemic segments during hyperemia (ischemia defined as absolute MBF ≤2.0 ml/kg/min) as measured by adenosine stress 15O-H2O PET(Baseline through Week 8)
- Change in total ischemia burden measured as ischemia score summed across all segments as measured by adenosine stress 15O-H2O PET(Baseline through Week 8)
- Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET(Baseline through Week 8)
研究者
研究点 (1)
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