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

JAB-21822-1009

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

2023-05-12

2023-06-14

2023-06-14

Completed

Early phase I

18

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is an open-label,randomized, 2-cycle,2-period crossover,food effect study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2024-01-05