NCT06506994已完成1 期
An Open Label, Tolvaptan-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Ascending Dose of HRS-9057 in Heart Failure With Volume Overload
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
- 25
- 试验地点
- 1
- 主要终点
- The incidence and severity of any adverse events (AEs)
研究概览
简要总结
The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. A total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive HRS-9057 injection or Tolvaptan tablets.
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
- None
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
- •Male or female, age 18-75 years at the time of signing informed consent.
- •Diagnosed as chronic heart failure at least 1 month prior to screening.
- •Patients with CHF in whom lower limb edema, pulmonary congestion, jugular venous distension or hepatomegaly due to volume overload is present despite diuretics treatment.
排除标准
- •Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening;
- •Hypovolemic hyponatremia.
研究组 & 干预措施
Treatment group A: HRS-9057/ Tolvaptan
Experimental
干预措施: HRS-9057 (Drug)
Treatment group A: HRS-9057/ Tolvaptan
Experimental
干预措施: Tolvaptan (Drug)
Treatment group B: HRS-9057/ Tolvaptan
Experimental
干预措施: HRS-9057 (Drug)
Treatment group B: HRS-9057/ Tolvaptan
Experimental
干预措施: Tolvaptan (Drug)
结局指标
主要结局
The incidence and severity of any adverse events (AEs)
时间窗: baseline up to Day 14
次要结局
- Cmax for HRS-9057(Predose on Day 1 through Day 6)
- Serum osmolality(Predose on Day 1 through Day 6)
- Urine osmolality(Predose on Day 1 through Day 7)
- Jugular venous distension change from baseline(baseline to Day 8)
- Tmax for HRS-9057(Predose on Day 1 through Day 6)
- Serum sodium concentration(Predose on Day 1 through Day 6)
- Daily urine volume(Predose on Day 1 through Day 7)
- Daily fluid balance(Predose on Day 1 through Day 7)
- Body weight(baseline to Day 8)
- New York Heart Association (NYHA) classification change from baseline(baseline to Day 8)
- Lower limb edema change from baseline(baseline to Day 8)
- Pulmonary congestion change from baseline(baseline to Day 8)
研究者
研究点 (1)
Loading locations...
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