NCT07230418已完成1 期
A Double-blind, Randomized, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects. This study will also explore food effect and the effect of HRS-3095 on CYP3A4 metabolic enzymes.
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
- •Able to comprehend and willing to sign an informed consent form (ICF);
- •Male and female healthy subjects with an age range between 18 and 55 years (inclusive);
- •Body mass index between 18.0 and 32.0 kg/m2 (inclusive), and the body weight is ≥ 50 kg for men and ≥ 45 kg for women;
- •For healthy subjects, no clinically significant abnormalities;
- •Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods.
排除标准
- •Known medical history or clinical manifestation of circulatory, endocrine, neurological, digestive, respiratory, hematological, immunological, psychiatric diseases, metabolic disorders, or any other condition that may interfere with the trial results, as determined by the Investigator;
- •Any condition or disease that may affect drug absorption, distribution, metabolism, or excretion, as determined by the Investigator;
- •History of recurrent drug allergies, or a physician-diagnosed and treatment-requiring allergic disease, or known allergy to any component of the investigational product;
- •History of an infection requiring systemic antimicrobial therapy within 2 weeks prior to screening or within 2 weeks before the first dose of the investigational product.
研究组 & 干预措施
HRS-3095 Group
Experimental
干预措施: HRS-3095 Tablet (Drug)
HRS-3095 Placebo Group
Placebo Comparator
干预措施: HRS-3095 Placebo Tablet (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to 21 days.
Incidence of serious adverse events (SAEs)
时间窗: Up to 21 days.
次要结局
- Maximum concentration (Cmax)(Up to 17 days.)
- Time of maximum concentration (Tmax)(Up to 17 days.)
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last)(Up to 17 days.)
- Area under the concentration-time curve from time zero to infinity (AUC0-inf)(Up to 17 days.)
- Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)(Up to 17 days.)
- Elimination half-life (t1/2)(Up to 17 days.)
- Apparent clearance (CL/F)(Up to 17 days.)
- Apparent volume of distribution (Vz/F)(Up to 17 days.)
研究者
研究点 (1)
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