NCT06798675尚未招募2 期
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING CLINICAL TRIAL TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF nC-001 IN PATIENTS WITH CHRONIC EUVOLEMIC HYPONATREMIA
nephCentric0 个研究点目标入组 24 人开始时间: 2025年8月最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Serum Urea and Sodium (Na)
研究概览
简要总结
CHRONIC EUVOLEMIC HYPONATREMIA
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥18 and ≤85 years of age
- •Diagnosis of chronic euvolemic hyponatremia
排除标准
- •Hyponatremia assessed by the Investigator to be hypervolemic, hypovolemic, or due to psychogenic polydipsia
研究组 & 干预措施
15gm
Active Comparator
干预措施: nC-001 (Drug)
30gm
Active Comparator
干预措施: nC-001 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Serum Urea and Sodium (Na)
时间窗: 24 hrs
次要结局
- Safety(15 days)
- Tolerability(1 day)
研究者
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