NCT05274516已完成1 期
Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetics of HRS-2261, the Effects of Food on the Pharmacokinetics of HRS-2261, and the Effects of HRS-2261 on CYP3A4 Metabolic Enzymes in Healthy Subjects After Single and Multiple Oral Administration
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2022年3月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Number and severity of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind, placebo controlled, randomized study design. The influence of food on the pharmacokinetics of HRS-2261 and the effects of HRS-2261 on CYP3A4 metabolic enzymes will also be investigated.
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 and willing to provide a written informed consent.
- •Age 18 to 55 years (inclusive).
- •Weight of male subjects ≥50 kg, female ≥45kg, body mass index (BMI) 19-26 kg/m2 (inclusive).
- •Medical examination (including physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound and chest radiography) normal or abnormal with no clinical significance.
排除标准
- •Any clinically serious diseases such as circulatory, endocrine, nervous, digestive, respiratory, blood, immune, mental and metabolic abnormalities or any other diseases that investigator determines may interfere with the test results.
- •Subjects with severe infection, severe trauma or major surgical operation within 3 months prior to screening; Subjects who plan to undergo surgery during the trial period and within two weeks after the trial.
- •Treated with any drug that inhibits or induces drug metabolism in the liver within 1 month prior to administration.
- •Subjects have any condition or medical condition that affects absorption, metabolism, and/or excretion of the study drug according to the investigator.
- •Subjects enrolled in clinical trials of any drug or medical device within 3 months prior to screening, or within 5 half-lives of the drug before screening.
- •Subjects who had a history of smoking in the previous 3 months (average daily smoking > 5 cigarettes), or who could not stop using any tobacco products during the test period.
- •Subjects who consumed more than 15g of alcohol per day on average (15g of alcohol is equivalent to 450 mL beer, 150 mL wine or about 50mL low-alcohol white wine) or tested positive for alcohol during the 3 months prior to screening, or who could not abstain from alcohol during the test period.
- •Subjects with a history of drug abuse, drug dependence or positive drug screening.
- •Determined by the investigator to be unfit to participate in this clinical trial.
研究组 & 干预措施
Single Ascending Doses, 6 dose levels
Experimental
HRS-2261 oral tablet Matching placebo to HRS-2261
干预措施: HRS-2261 tablet、placebo (Drug)
Multiple Ascending Doses, 3 dose levels
Experimental
HRS-2261 oral tablet Matching placebo to HRS-2261
干预措施: HRS-2261 tablet、placebo (Drug)
结局指标
主要结局
Number and severity of treatment emergent adverse events (TEAEs)
时间窗: up to 7 days after the last dose
Number and severity of TEAEs collected from dosing until follow up 7 days after last dose
次要结局
- Maximum plasma concentration (Cmax)(up to 7 days after the last dose)
- Area under the curve (AUC)(up to 7 days after the last dose)
- Maximum plasma concentration (Cmax) under fed conditions(up to 7 days after the last dose)
- Area under the curve (AUC) under fed conditions(up to 7 days after the last dose)
研究者
研究点 (1)
Loading locations...
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