A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of RAY1216 and the Effect of Food on RAY1216 Pharmacokinetics in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in single ascending dose
研究概览
简要总结
This is double-blind,randomized, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety, tolerability and drug-drug interaction of RAY1216, and the effect of food on RAY1216 Pharmacokinetics.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（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 subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- •Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Subjects (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
- •Males and female subjects between 18-50 years (Both inclusive). 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).
- •Physical condition and vital signs: Normal or abnormality has no clinical significance.
排除标准
- •Known hypersensitivity and/or allergy to some drugs and food, especially for the composition that is similar to the investigative product;
- •The average daily smoking are more than 5 cigarettes within 3 months prior to screening.
- •Known history of drug or alcohol abuse.(defined as consumption of 14 units of alcohol per week: 1 unit = 285 ml of beer; or the equivalent of 25 ml of spirit, or 100 ml of wine )
- •Subjects who donated blood or bleeding profusely (> 400 mL) in the 3 months preceding study screening.
- •Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs, include a history of frequent nausea or vomit causes by any etiology.
- •History or presence of any disease or condition known to increase the risk of bleeding , eg. acute gastritis, duodenal ulcer, etc.
- •Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
- •History of having any special food (including dragon fruit, mango, grapefruit, etc.), strenuous exercises, or other factors may interfere with the absorption, distribution, metabolism, or excretion of drug within 7 days prior to screening.
- •Inability to consume the food provided in the study ( a high fat diet).This requirement only applies to subjects under fed condition.
- •Presence of clinically significant abnormalities in ECG or QTcF>450ms
- •Subjects who may not complete the study for other reasons or should not be included in the study in the opinion of the investigator.
研究组 & 干预措施
RAY1216 dose 9（food effect）
food effect on single dose
干预措施: RAY1216 dose 9 (Drug)
RAY1216 dose 10（food effect）
food effect on single dose
干预措施: RAY1216 dose 10 (Drug)
RAY1216 dose 6
MAD
干预措施: RAY1216 dose 6 (Drug)
RAY1216 dose 7
MAD
干预措施: RAY1216 dose 7 (Drug)
RAY1216 dose 8
MAD
干预措施: RAY1216 dose 8 (Drug)
RAY1216 dose 1
SAD
干预措施: RAY1216 dose 1 (Drug)
RAY1216 dose 2
SAD
干预措施: RAY1216 dose 2 (Drug)
RAY1216 dose 3
SAD
干预措施: RAY1216 dose 3 (Drug)
RAY1216 dose 4（DDI）
drug-drug interaction
干预措施: RAY1216 dose 4 &ritonavir (Drug)
RAY1216 dose 5
MAD
干预措施: RAY1216 dose 5 (Drug)
结局指标
主要结局
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in single ascending dose
时间窗: Day 1 to Day 5
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in multiple ascending dose
时间窗: Day 1 to Day 9
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in food effect part
时间窗: Day 1 to Day 21
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in DDI part
时间窗: Day 1 to Day 15
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
次要结局
- To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmax)(Day 1 to Day 9)
- To determine the effect of food on the PK of RAY1216 single dose(AUC0-∞)(Day 1 to Day 21)
- To determine the effect of food on the PK of RAY1216 single dose(Cmax)(Day 1 to Day 21)
- To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmin)(Day 1 to Day 9)
- To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(Cmax)(Day 1 to Day 15)
- To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(AUC0-∞)(Day 1 to Day 15)