A Phase I, Single-center, Randomized, Open-label, 2-cycle,2-period Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of JAB-21822 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Plasma concentration ( Cmax)
研究概览
简要总结
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of JAB-21822 following single dose administration with and without a meal
详细描述
This is an open-label,randomized, 2-cycle,2-period crossover,food effect study. On Day 1 of each period, subjects will receive a single oral dose of JAB-21822 administered either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for JAB-21822 will be collected predose and postdose. There will be a washout period between doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female , between 18 and 45 years of age
- •Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg；BMI within the range of 19 to 25 kg/m2, inclusive
- •No clinically significant abnormalities identified in the judgement of investigator at screening
- •Written informed consent prior to any study specific procedures
排除标准
- •History of clinically significant disease or disorder
- •History of interstitial pneumonia, pulmonary fibrosis, and other interstitial lung diseases
- •History of dysphagia or any gastrointestinal disease that would potentially alter absorption of drug
- •COVID-19 positive at screening or baseline
- •Allergic to JAB-21822 and any of the tablet's ingredients, history of hypersensitivity or allergy to drug or food
- •Received surgical procedure within 3 months at screening
- •Blood donation within the 3 months or planing to donate during the study
- •Participated in another clinical trial of biological agents within 6 months at screening, or any other clinical trial within 3 months at screening
- •History of drug abuse or positive urine drug test
- •Received the vaccine within 3 months at screening or planning to receive during the study
- •Overtake of achole,tea and coffee prior to first dosing and unable to control during the study
- •Special dietary requirements or unable to control during the study
- •HIV, HBV, HCV, and syphilis positive
- •Pregnant or breast-feeding women or positive of blood pregnancy test
- •Subjects who are considered to be unacceptable in this study under the opinion of the investigator
研究组 & 干预措施
A-JAB-21822
Dosing in the fasted state followed by fed dosing
干预措施: JAB-21822 (Drug)
B-JAB-21822
Dosing in the fed state followed by fasted dosing
干预措施: JAB-21822 (Drug)
结局指标
主要结局
Plasma concentration ( Cmax)
时间窗: 31days
Highest observed plasma concentration of JAB-21822
Area under plasma concentration (AUC) 0 to t
时间窗: 31days
Area under the plasma concentration time curve of JAB-21822
Area under plasma concentration (AUC) 0 to∞
时间窗: 31days
Area under the plasma concentration time curve of JAB-21822
次要结局
- Absorption lag-time (Tlag)(31days)
- Number of subjects with abnormal electrocardiogram (12-lead ECG)(31days)
- Apparent volume of distribution (Vz/F)(31days)
- Concentration half-life (T1/2)(31days)
- Apparent clearance (CL/F)(31days)
- Number of participants with adverse events (AEs) and serious adverse events(SAEs)(31days)
- Number of subjects with abnormal lab parameters(31days)
- Time to achieve Cmax (Tmax)(31days)
- Elimination rate constant (λz)(31days)
- Number of subjects with abnormal pulse rate(31days)
- Number of subjects with abnormal systolic and diastolic blood pressure(31days)
- Number of subjects with abnormal respiratory rate(31days)
- Number of subjects with abnormal body temperature(31days)