NCT04045405已完成1 期
Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess Safety, PK and PD Parameters of CDR132L in Patients With Stable Heart Failure of Ischemic Origin (NYHA 1- 3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events [safety and tolerability]
研究概览
简要总结
This is a Phase I, randomized, double-blind, placebo-controlled study to assess safety, pharmacokinetics and pharmacodynamic parameters of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).
详细描述
Objectives:
Primary
• To assess the safety of one single and one repeated dose of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).
Secondary • To characterize the pharmacokinetic (PK) profile of CDR132L in patients with stable heart failure of ischemic origin.
Exploratory
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable heart failure of ischemic origin
排除标准
- •Heart failure of non-ischemic origin (hypertensive heart disease, myocarditis, alcoholic cardiomyopathy and cardiac dysfunction due to rapid atrial fibrillation),
研究组 & 干预措施
CDR132L
Experimental
干预措施: CDR132L (Drug)
Saline
Placebo Comparator
干预措施: CDR132L (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events [safety and tolerability]
时间窗: 4 months
The incidence and severity of treatment-emergent adverse events (TEAEs)
次要结局
- Maximum plasma concentration (Cmax)(4 months)
- Time to reach maximum plasma concentration (Tmax)(4 months)
- Area under the curve (AUC0-t)(4 months)
- Area under the curve (AUC0-inf)(4 months)
- Blood clearance (CL)(4 months)
- Half life (t1/2)(4 months)
- Volume of distribution (Vdss)(4 months)
研究者
研究点 (1)
Loading locations...
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