NCT07448194招募中1 期
A Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of HW241045 Tablets Following a Single Dose in Healthy Subjects: A Single-center, Randomized, Double-blind, Placebo-controlled Study
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年11月24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
- 56
- 试验地点
- 1
- 主要终点
- The number and severity of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This is a Phase Ia, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetic (PK) of HW241045 in healthy subjects following a single ascending dose.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects have been fully informed of the trial's purpose, nature, methodology, and potential adverse reactions. They voluntarily participate in the trial and sign the informed consent form prior to the initiation of any study procedures;
- •Healthy male and female subjects aged 18 to 55 years;
- •Female subjects must have a body weight of ≥ 45 kg and male subjects ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m².
排除标准
- •Subjects with a history of or current severe clinical disease involving any of the following systems: circulatory, endocrine, nervous, digestive, respiratory, hematological, immune, mental, or metabolic systems; or subjects with any other disease that the investigator judges may interfere with the study results;
- •Subjects with a history of severe trauma or major surgery within 3 months prior to screening; or subjects planning to undergo surgery during the trial period or within two weeks after study completion;
- •Subjects with a history of gastrointestinal, hepatic, or renal diseases that affect drug absorption or metabolism; or those with conditions known or suspected to interfere with drug ingestion, transport, absorption, distribution, metabolism, or excretion;
- •Subjects with clinically significant abnormalities in any screening test results as judged by the investigator;
- •Subjects with a history of drug or food allergy, allergic disorders, or atopic diathesis; or those with confirmed hypersensitivity to any component of the investigational drug;
- •Subjects with difficult venous blood collection, or whose physical condition cannot tolerate intensive blood sampling;
- •Not suitable for this study as judged by the investigator.
研究组 & 干预措施
HW241045
Experimental
Single oral dose of HW241045
干预措施: HW241045 (Drug)
Placebo
Placebo Comparator
Single oral dose of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The number and severity of treatment emergent adverse events (TEAEs)
时间窗: Up to 48 hours
To assess the safety and tolerability of single oral dose of HW241045 in healthy adult volunteers
次要结局
未报告次要终点
研究者
研究点 (1)
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