A Food Effect Study of JAB-21822 in Healthy Subjects

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Food Effect in Healthy Participants

Intervention / Treatment
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* Drug: JAB-21822
* Drug: JAB-21822


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is an open-label,randomized, 2-cycle,2-period crossover,food effect study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-JAB-21822<br>Dosing in the fasted state followed by fed dosing | Drug: JAB-21822<br>* 2 discrete single doses<br>|
| Experimental: B-JAB-21822<br>Dosing in the fed state followed by fasted dosing | Drug: JAB-21822<br>* 2 discrete single doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under plasma concentration (AUC) 0 to∞ | Area under the plasma concentration time curve of JAB-21822 | 31days | 
| Area under plasma concentration (AUC) 0 to t | Area under the plasma concentration time curve of JAB-21822 | 31days | 
| Plasma concentration ( Cmax) | Highest observed plasma concentration of JAB-21822 | 31days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve Cmax (Tmax) | Time of highest observed plasma concentration of JAB-21822 | 31days | 
| Elimination rate constant (λz) | Elimination rate constant based on the terminal phase of unchanged form of JAB-21822 | 31days | 
| Concentration half-life (T1/2) | Elimination half-life of unchanged form of JAB-21822 | 31days | 
| Absorption lag-time (Tlag) | Elimination lag-time of JAB-21822 | 31days | 
| Apparent volume of distribution (Vz/F) | Apparent volume of distribution based on the terminal phase of unchanged form of JAB-21822 | 31days | 
| Apparent clearance (CL/F) | Apparent total body clearance of unchanged form of JAB-21822 | 31days | 
| Number of participants with adverse events (AEs) and serious adverse events(SAEs) | Incidence,duration and severity of adverse events and serious adverse events according to NCI-CTCAE v5.0 | 31days | 
| Number of subjects with abnormal lab parameters | Abnormal values of lab parameters | 31days | 
| Number of subjects with abnormal electrocardiogram (12-lead ECG) | Prolongation of the QTc interval | 31days | 
| Number of subjects with abnormal systolic and diastolic blood pressure | Abnormal values in systolic and diastolic blood pressure | 31days | 
| Number of subjects with abnormal pulse rate | Abnormal values in pulse rate | 31days | 
| Number of subjects with abnormal respiratory rate | Abnormal values in respiratory rate | 31days | 
| Number of subjects with abnormal body temperature | Abnormal values of body temperature | 31days |