A Food Effect Study of JAB-21822 in Healthy Subjects

NCT ID: NCT05875493

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-12
• Study Completion Date: 2023-06-14

Brief Summary

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

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.

Conditions

Food Effect in Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A-JAB-21822

Dosing in the fasted state followed by fed dosing

Group Type: EXPERIMENTAL

JAB-21822

Intervention Type: DRUG

2 discrete single doses

B-JAB-21822

Dosing in the fed state followed by fasted dosing

Group Type: EXPERIMENTAL

JAB-21822

Intervention Type: DRUG

2 discrete single doses

Interventions

JAB-21822

2 discrete single doses

Intervention Type: DRUG

JAB-21822

2 discrete single doses

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allist Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

He Qing B.Pharm

Role: PRINCIPAL_INVESTIGATOR

Beijing Gaobo Boren Hospital

Locations

Beijing GoBroad Boren Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

JAB-21822-1009

Identifier Type: -

Identifier Source: org_study_id