NCT07698756尚未招募1 期
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect Following Single and Multiple Oral Doses of HRS-8797 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
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Safety: incidence of adverse event (AE), serious adverse event (SAE)
研究概览
简要总结
The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy 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
- 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
- •Healthy men and women aged 18 to 55 years old at informed consent signing
- •Male body weight ≥50 kg , female ≥45 kg; BMI 18 to 28 kg/m² at screening and baseline
- •Have no clinically significant abnormalities at screening and baseline
- •Fertile females and males with fertile female partners: effective contraception consent, and sustained until 4 weeks after the last dose (abstinence or highly effective contraception); no sperm/egg donation
排除标准
- •A history or current severe diseases of multiple systems, or other diseases interfering with trial results.
- •Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial.
- •Blood donation/severe blood loss (≥400 mL) within 3 months, blood transfusion within 4 weeks before screening; planned blood donation during the trial.
- •History of drug abuse/dependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned
- •participation during the trial; within 5 half-lives of a prior drug (whichever is longer).
- •Smoking history (≥5 cigarettes/day) within 4 weeks before screening; inability to abstain from tobacco during the trial;
- •Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening.
- •Special dietary requirements and inability to comply with the unified diet.
- •Difficulty in swallowing/venous blood collection; intolerance to intensive blood sampling.
- •Other circumstances deemed unsuitable for trial participation by Researcher.
研究组 & 干预措施
single ascending dose (SAD) cohorts
Experimental
Subjects will be assigned to one of 5-6 planned dose cohorts and receive single dose of HRS-8797 or placebo
干预措施: Placebo (Drug)
single ascending dose (SAD) cohorts
Experimental
Subjects will be assigned to one of 5-6 planned dose cohorts and receive single dose of HRS-8797 or placebo
干预措施: HRS-8797 (Drug)
multiple ascending dose (MAD) cohorts
Experimental
Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-8797 or placebo
干预措施: HRS-8797 (Drug)
multiple ascending dose (MAD) cohorts
Experimental
Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-8797 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: incidence of adverse event (AE), serious adverse event (SAE)
时间窗: Day1-Day15 (SAD)；Day1-Day15 (FE)；Day1-Day21 (MAD)
次要结局
- PK parameter of HRS-8797 : Area under the concentration time curve (AUC)(Days 1-19)
- PK parameter of HRS-8797: Maximum Plasma Concentration (Cmax)(Days 1-19)
- PK parameter of HRS-8797 : Time to maximum plasma concentration (Tmax)(Days 1-19)
- PK parameter of HRS-8797 : Apparent clearance (CL/F)(Days 1-19)
研究者
研究点 (1)
Loading locations...
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