NCT07301333已完成1 期
A Phase 1 Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food on the Bioavailability of HRS-6257 in Healthy Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The incidence and severity of adverse events
研究概览
简要总结
This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy volunteers.
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
- •Aged between 18 and 55 years old (based on the time of signing the informed consent form), both males and females are eligible.
- •The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m².
- •Female subjects must be non-pregnant or non-childbearing potential;
- •Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.
排除标准
- •History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease;
- •Known or suspected hypersensitivity to trial product(s) or related products;
- •12-lead ECG demonstrating QTcF >450 msec or history or risk factors for QT prolongation;
- •Blood donation of more than 200 mL within the last 6 months
- •Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 7 half-lives;
- •Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse.
- •Previous administration with an investigational product (drug or vaccine) within 3 months;
研究组 & 干预措施
placebo group
Placebo Comparator
干预措施: placebo (Drug)
HRS-6257 group
Experimental
干预措施: HRS-6257 (Drug)
结局指标
主要结局
The incidence and severity of adverse events
时间窗: from ICF signing date to Day 14 or Day 21 or Day 27
次要结局
- AUC of HRS-6257(0 hour to 72 hour after administration)
- t1/2 of HRS-6257(0 hour to 72 hour after administration)
- Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses(from ICF signing date to Day 14)
- Cmax of HRS-6257(0 hour to 72 hour after administration)
- Tmax of HRS-6257(0 hour to 72 hour after administration)
- CL/F of HRS-6257(0 hour to 72 hour after administration)
- Vz/F of HRS-6257(0 hour to 72 hour after administration)
- Pain tolerance time for the Cold Pain Test(Day 1 to Day 1 or Day 14)
研究者
研究点 (2)
Loading locations...
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