NCT06926218尚未招募1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HSK47388 in Healthy Volunteers
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK47388 in healthy adult participants and preliminarily evaluate the PD of HSK47388
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- •Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.
- •Able and willing to attend the necessary visits to the study site
排除标准
- •Participants with any disease history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI.
- •Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol.
- •Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.
研究组 & 干预措施
HSK47388
Experimental
Single oral doses of HSK47388
干预措施: HSK47388 (Drug)
placebo
Experimental
single oral dose of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE
时间窗: 7 days after single dose
The incidence, severity, and relationship to IP of AEs. Change from Baseline in clinical laboratory parameters (ie, hematology, serum chemistry, coagulation, and urinalysis parameters), physical examination findings, vital signs
次要结局
- Cmax(Predose up to Day 5 postdose)
- Tmax(Predose up to Day 5 postdose)
- AUC(Predose up to Day 5 postdose)
- t1/2(Predose up to Day 5 postdose)
- CL/F(Predose up to Day 5 postdose)
研究者
研究点 (1)
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