NCT07373457招募中1 期
A Single-Center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect of HW201877 in Healthy Volunteers.
Wuhan Humanwell Innovative Drug Research and Development Center Limited Company1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年6月26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
- 104
- 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 I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).
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
- •Before enrollment in the study, each subject shall sign the informed consent form and be fully apprised of the study content, implementation procedures and potential adverse reactions.
- •Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 6 months after the last dose administration.
- •18 years to 55 years (inclusive), male and female.
- •Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-28 kg/m2 (inclusive) .
排除标准
- •Smoking more than 5 cigarettes per day within 3 months prior to screening.
- •Allergic diathesis (with a history of allergies to multiple drugs and foods).
- •A history of drug abuse and/or alcoholism (consuming 14 units of alcohol per week; 1 unit = 285 mL of beer, 25 mL of distilled spirits, or 100 mL of wine).
- •Have taken any medications that alter hepatic enzyme activity within 28 days prior to screening.
- •Have consumed special diets (including pitaya, mango, lime, grapefruit, carambola, orange, grapefruit or grapefruit-containing products, etc.) or engaged in strenuous exercise within 2 weeks prior to screening, or having other factors that may affect the absorption, distribution, metabolism and excretion of the study drug.
- •Have taken any investigational drugs or participated in any other clinical drug trials within 3 months prior to the first administration of the study drug.
- •Clinically significant abnormalities in clinical laboratory tests, or a history of clinically significant findings of the following diseases within 12 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardio-cerebrovascular diseases).
- •Unable to tolerate venipuncture, or with a history of needle phobia or hematophobia.
- •Not suitable for this study as judged by the investigator.
研究组 & 干预措施
HW201877 capsules
Experimental
Single or multiple oral doses of HW201877 capsules, and food effect of HW201877 capsules
干预措施: HW201877 capsules (Drug)
Placebo
Placebo Comparator
Single or multiple oral doses of placebo, and food effect 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: Day 1 to Day 5
To assess the safety and tolerability of single or multiple oral dose of HW201877 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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