NCT06435676已完成1 期
A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of HRS9531 Tablets in Healthy Subjects
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
- 72
- 试验地点
- 1
- 主要终点
- MAD Stage: Number of Adverse Events
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 HRS9531tablets in healthy subjects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the trial procedures, be able and willing to provide a written informed consent.
- •18-55 years of age at the time of signing informed consent.
- •SAD stage: Body weight ≥50 kg,19.0 ≤BMI≤ 35.0 kg/m2 at screening visit. MAD stage: 24.0 ≤BMI≤ 35.0 kg/m2 at screening visit.
- •Subjects with good general health, no clinically significant abnormalities.
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
- •Abnormal and clinically significant blood pressure at screening.
- •Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
- •Participation in other clinical trials.
- •Presence of any clinically significant results in examination at screening visit.
- •Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
- •Presence of - clinically significant ECG results.
- •Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
- •Addiction to tobacco and alcohol.
- •In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
研究组 & 干预措施
SAD Stage: HRS9531
Experimental
Administered po once
干预措施: HRS9531 (Drug)
SAD Stage: placebo
Placebo Comparator
Administered po once
干预措施: Placebo (Drug)
MAD Stage: HRS9531
Experimental
Administered po for multiple dose
干预措施: HRS9531 (Drug)
MAD Stage: placebo
Placebo Comparator
Administered po for multiple dose
干预措施: Placebo (Drug)
结局指标
主要结局
MAD Stage: Number of Adverse Events
时间窗: 63 days
SAD Stage: Number of Adverse Events
时间窗: 36 days
次要结局
- Immunogenicity qualitative(63 days)
- Plasma Concentration-Time to Peak (Tmax) of HRS9531(63 days)
- Glucose(35 days)
- Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531(63 days)
研究者
研究点 (1)
Loading locations...
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