A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate Pharmacokinetics, Safety and Tolerability of RAY1216 in Elder Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to infinity (AUCinf)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and PK of Leritrelvir in elder participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- •Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI<28 kg/m2,BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
- •Heart rate between 50-100 beats/min, Body temperature between 35.7-37.5℃
- •Young Participants Only:
- •Participant must be ≥18 to ≤45 years old
- •Elder Participants Only:
- •Participant must be ≥65 years old
排除标准
- •Participants with an allergic disposition (multiple drug and food allergies)
- •Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months.
- •Participants with clinically significant disease, such as gastrointestinal disease, infection (e.g., respiratory or central nervous system infection),within 2 weeks before screening;
- •Participants who could not tolerate blood collection by venipuncture and/or had a history of dizzy with blood and needles
- •Young Participants Only:
- •Participants had taken or planned to take any prescription medication, over-the-counter medication, vitamin product, or herbal medicine within 2 weeks before screening;
- •Physical examination, vital signs, laboratory tests (blood routine+CRP, urine routine + urine sediment, blood biochemistry, coagulation function, infectious disease test, glycosylated hemoglobin test), 12-lead electrocardiogram, chest CT, abdominal color Doppler ultrasound and other examinations have clinical significance
- •Elder Participants Only:
- •Participants had a history of or evidence of cardiovascular disease before screening，including uncontrolled hypertension, orthostatic hypotension, severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within the past 6 months before screening, or history of tachycardia/bradycardia requiring medical treatment, and degree II-III atrioventricular block.
- •Participants who had other serious organ-systemic serious diseases at screening, including but not limited to respiratory, neurologic, hematologic, endocrine, oncologic, immunologic, psychiatric, or cardiocerebrovascular diseases, and was judged by the investigator to be ineligible for participation in the trial
研究组 & 干预措施
young participates
16 young participants(between 18~45 years old) will be given Leritrelvir. D1：400mg QD D3-D5:400mg TID D6:400mg QD
干预措施: Leritrelvir (Drug)
Elder participates
16 elder participants(Age≥65 years old) will be given Leritrelvir. 16 young participants(between 18~45 years old) will be given Leritrelvir. D1：400mg QD D3-D5:400mg TID D6:400mg QD
干预措施: Leritrelvir (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to infinity (AUCinf)
时间窗: Day1~Day8
The AUCinf of a single dose of Leritrelvir in elder participants and young participates will be evaluated and compared.
Maximum observed plasma concentration (Cmax)
时间窗: Day1~Day8
The Cmax of a single dose of Leritrelvir in elder participants and young participates will be evaluated and compared.
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)
时间窗: Day1~Day8
The AUClast of a single dose of Leritrelvir in elder participants and young participates will be evaluated and compared.
次要结局
- Number of participants with drug-related adverse events as assessed by CTCAE v5.0(Day1~Day13)