NCT05875493

A Food Effect Study of JAB-21822 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Allist Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	JAB-21822	2 discrete single doses
DRUG	JAB-21822	2 discrete single doses

Timeline

• Start date: 2023-05-12
• Primary completion: 2023-06-14
• Completion: 2023-06-14
• First posted: 2023-05-25
• Last updated: 2025-04-04

Locations

1 site across 1 country: China