A Food Effect Study of JAB-21822 in Healthy Subjects

Allist Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Food Effect in Healthy Participants

Treatments

Drug: JAB-21822

Study type

Interventional

Funder types

Industry

Identifiers

NCT05875493

JAB-21822-1009

Details and patient eligibility

About

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

Full description

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.

Enrollment

18 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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