NCT07551167
尚未招募
1 期
A Randomized, Double-Blind, Dose-Escalation, Placebo-Parallel Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HRS-5765 in Healthy Subjects, as Well as the Effect of Food on the Pharmacokinetics of HRS-5765 and the Effect of HRS-5765 on CYP3A4 Metabolic Enzymes
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Incidence of adverse event (AE)
概览
简要总结
The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of HRS-5765 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women aged 18 to 65 years old at informed consent signing.
- •Male body weight ≥ 50 kg and \< 90.0 kg, female ≥ 45 kg and \< 90.0 kg; BMI 19 to 26 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 1 week 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
HRS-5765 group
Experimental
Participants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765.
干预措施: HRS-5765 Tablet (Drug)
HRS-5765 placebo group
Placebo Comparator
Participants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765 placebo.
干预措施: HRS-5765 Tablet Placebo (Drug)
结局指标
主要结局
Incidence of adverse event (AE)
时间窗: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).
Safety parameter.
Incidence of serious adverse event (SAE)
时间窗: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).
Safety parameter.
次要结局
- Area under the concentration-time curve (AUC)(Day 1-Day 18.)
研究者
研究点 (1)
Loading locations...
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