NCT07403552招募中1 期
A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
Ensho Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年1月31日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Maximum Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of NSHO-101 in Healthy Participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants (males and females) at least 18 years of age
- •Ability to provide written informed consent
- •In good heath as determined by medical evaluation,
- •Willing and able to comply with trial restrictions, procedures, and requirements
排除标准
- •Known sensitivity to any components of the IMP
- •History of relevant drug hypersensitivity
- •Presents or has a history of clinically significant diseases
- •History of difficulty swallowing tablets or capsules.
- •Any physical examination findings or medical history that might place the participant at an unacceptable risk for participation in this trial.
研究组 & 干预措施
NSHO-101 Dose A
Experimental
Oral dose A of NSHO-101 QD for 14 days
干预措施: NSHO-101 (Drug)
NSHO-101 Dose B
Experimental
Oral dose B of NSHO-101 QD for 14 days
干预措施: NSHO-101 (Drug)
结局指标
主要结局
Pharmacokinetics: Maximum Concentration (Cmax)
时间窗: Day 1 to Day 18
Pharmacokinetics: Area Under the Concentration Curve (AUC)
时间窗: Day 1 to Day 18
Pharmacokinetics: Trough Concentration (Ctrough)
时间窗: Day 1 to Day 18
Pharmacokinetics: Half-life
时间窗: Day 1 to Day 18
Pharmacokinetics: Time to Maximum Concentration (tmax)
时间窗: Day 1 to Day 18
次要结局
- Treatment Emergent Adverse Events(Day 1 to 14)
- Serious Treatment Emergent Adverse Events(Day 1 to Day 14)
研究者
研究点 (1)
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