NCT07737496招募中1 期
A Phase 1, Randomized, Double-Blind, Single-Center, Dose-Escalation, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW243040 in Healthy Participants
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2026年8月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- The incidence and severity of adverse events
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled clinical trial intended to evaluate the safety, tolerability and pharmacokinetic profiles of HW243040 following single and multiple administrations in healthy study participants.
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
- Double (Participant, Investigator)
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
- •Informed consent must be obtained/signed prior to trial participation.
- •Aged between 18 and 55 years old, both healthy males and females are eligible.
- •Female participates must have a body weight of ≥ 45 kg and male participates ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m^2.
排除标准
- •History or presence of any clinically severe disorders of urinary, cardiovascular, endocrine, nervous, gastrointestinal, respiratory, hematologic, immune systems, psychiatric illnesses or metabolic abnormalities; or other conditions judged by the Investigator to confound trial outcomes, e.g., intestinal diseases (irritable bowel syndrome), urinary tract infections.
- •History of malignant tumors (except for cancer with confirmed cure or remission for ≥5 years, radically resected basal or squamous cell skin cancer, carcinoma in situ of the cervix, and resected colonic polyps).
- •Any conditions or diseases that, in the Investigator's judgment, may affect the absorption, metabolism and/or excretion of the investigational product.
- •History of drug abuse or dependence.
- •Hypersensitivity to any ingredient of the study drug，or history of allergic disorders or allergic diathesis.
- •Any other condition that, in the opinion of the investigator, renders the participant unsuitable to participate in the study.
研究组 & 干预措施
Placebo group
Placebo Comparator
Single or multiple dose of placebo will be administered orally.
干预措施: Placebo (Drug)
HW243040 group
Experimental
Single or multiple dose of HW243040 will be administered orally.
干预措施: HW243040 (Drug)
结局指标
主要结局
The incidence and severity of adverse events
时间窗: Up to day 11
次要结局
- Maximum Concentration (Cmax) of HW243040(Up to day 11)
- Area Under the Concentration Versus Time Curve (AUC) of HW243040(Up to day 11)
- Time for Cmax (Tmax) of HW243040(Up to day 11)
- Half-life of HW243040(Up to day 11)
研究者
研究点 (2)
Loading locations...
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