NCT07150962招募中1 期
A Phase I Clinical Study Comparing the Relative Bioavailability, Safety and Tolerability of the First-generation and Second-generation Formulations of HRS9531 Tablets and Exploring the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Escalation of the Second-generation Formulation
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Area under the curve from Time Zero to Time of last quantifiable concentration (AUCtau)
研究概览
简要总结
This study aims to compare the relative bioavailability, safety and tolerability of the first-generation and second-generation formulations of HRS9531 tablets, as well as to explore the safety, tolerability and pharmacokinetic characteristics of the second-generation formulation in terms of single-dose escalation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
- •Male subjects aged 18-55 years on the date of signing informed consent (inclusive);
- •Body weight ≥65 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);
- •The weight change within the previous 3 months should not exceed 5 kilograms.
- •Based on the patient's past medical history, physical examination, vital signs, laboratory tests and electrocardiogram (ECG) examinations, the researchers determined that the overall overweight and obese subjects were included.
排除标准
- •Those who are known or suspected to be allergic to any component of the investigational drug or related products; or those who have a history of multiple or severe allergies to drugs or foods, or a history of severe immediate allergic reactions;
- •Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;
- •Having a history of hypertension or when the researchers determine during the screening that the blood pressure is abnormal and has clinical significance;
- •Those with a history of obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), conditions that affect gastric emptying (such as pyloric stenosis), or who have undergone any gastrointestinal surgery (such as weight loss surgery; except for intestinal polyp resection and appendectomy), or who had acute diarrhea within the previous 7 days; diarrhea is defined as watery stools and/or more than 3 bowel movements per day;
- •Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;
- •Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;
- •Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
- •Those who have a history of drug abuse or drug use, or who have a positive result in the urine drug screening test during the screening period;
- •Heavy drinkers (average weekly alcohol consumption of ≥ 14 units in the six months prior to screening: 1 unit of beer = 285 mL, or spirits = 25 mL, or wine = 100 mL; average daily smoking ≥ 5 cigarettes); those unable to quit smoking and drinking during the trial; those with positive alcohol blood tests.
研究组 & 干预措施
Multiple ascending dose group
Experimental
干预措施: HRS-9531 Tablet (Drug)
Single ascending dose group
Experimental
干预措施: HRS-9531 Tablet (Drug)
结局指标
主要结局
Area under the curve from Time Zero to Time of last quantifiable concentration (AUCtau)
时间窗: From Day 14 to Day 15.
Adverse event (AE)
时间窗: Screening period up to Day 35.
Serious adverse event (SAE)
时间窗: Screening period up to Day 35.
次要结局
- The maximum plasma concentration (Cmax)(On the 35th day after continuous administration.)
- Time to maximum plasma concentration (Tmax)(Post-dose from Day 1 to Day 183.)
- Area under the concentration-time curve (AUC)(On the 35th day after continuous administration.)
研究者
研究点 (1)
Loading locations...
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