A Food Effect Study of JAB-21822 in Healthy Subjects

Phase 1

Completed

• Conditions: Food Effect in Healthy Participants
• Interventions: Drug: JAB-21822

• Registration Number: NCT05875493
• Lead Sponsor: Allist Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2023-04-23
• Study Start: 2023-05-12
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-25
• Primary Completion: 2023-06-14
• Study Completion: 2023-06-14
• Status Verified: 2024-01
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A-JAB-21822	JAB-21822	Dosing in the fasted state followed by fed dosing
B-JAB-21822	JAB-21822	Dosing in the fed state followed by fasted dosing

Primary Outcome Measures

Name	Time	Method
Area under plasma concentration (AUC) 0 to∞	31days	Area under the plasma concentration time curve of JAB-21822
Plasma concentration ( Cmax)	31days	Highest observed plasma concentration of JAB-21822
Area under plasma concentration (AUC) 0 to t	31days	Area under the plasma concentration time curve of JAB-21822

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing GoBroad Boren Hospital; 🇨🇳 Beijing, Beijing, China