Mass Balance Study of [14C]JAB-21822

Phase 1

Completed

• Conditions: Mass Balance Study in Healthy Subjects
• Interventions: Drug: [14C]JAB-21822

• Registration Number: NCT05920941
• Lead Sponsor: Allist Pharmaceuticals, Inc.

Brief Summary

Mass Balance Study of \[14C\]JAB-21822 in China Healthy Subjects

Detailed Description

A phase I study to quantify the total mass balance in healthy subjects after a single dose of \[14C\]JAB-21822

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-25
• Study First Posted: 2023-06-27
• Study Start: 2023-07-08
• Primary Completion: 2023-08-09
• Study Completion: 2023-08-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

1. Healthy male subjects between the ages of 18 and 45 years (inclusive).
2. Subjects weighing ≥ 50 kg and Body Mass Index of 19.0 to 26.0 kg/m2.
3. Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.

Exclusion Criteria

1. With abnormal and clinically significant comprehensive physical examinations, vital signs, or laboratory examinations.
2. Has a positive test for HBV, HCV, HIV, or syphilis.
3. Known medical history judged by the investigator as not suitable for the study.
4. Known history of drug or food allergy.
5. Has drug or alcohol abuse history or positive drug or alcohol abuse test results.
6. Heavy smokers or caffeine addicts.
7. Has diseases or other conditions affecting the absorption, distribution, metabolism, and excretion of oral drugs.
8. Disagree to strict contraception within one year after the trial
9. Has any other conditions judged by the investigator as not suitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]JAB-21822	[14C]JAB-21822	Single oral dose of 800mg 14C\]JAB-2182 suspension

Primary Outcome Measures

Name	Time	Method
Total radioactivity in plasma PK: t1/2	up to 504 hours post dose	Elimination half-life
Recovery of total radioactivity in urine and fecal samples	up to 504 hours post dose	Mass balance recovery of total radioactivity in urine and fecal samples
Total radioactivity in plasma PK: Cmax	up to 504 hours post dose	Highest radioactivity observed plasma concentration
Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples	up to 504 hours post dose	Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites
Total radioactivity in plasma PK: Tmax	up to 504 hours post dose	Time for Cmax
Total radioactivity in plasma PK: Area under the curve	up to 504 hours post dose	Area under the plasma concentration time curve
Total radioactivity in plasma PK: MRT	up to 504 hours post dose	Mean residence time
Whole blood to plasma total radioactivity ratio	up to 504 hours post dose

Secondary Outcome Measures

Name	Time	Method
JAB-21822 PK: Tmax	up to 504 hours post dose	Time for Cmax of JAB-21822
JAB-21822 PK: Area under the curve	up to 504 hours post dose	Area under the plasma concentration time curve of JAB-21822
JAB-21822 PK: t1/2	up to 504 hours post dose	Elimination half-life of JAB-21822
JAB-21822 PK: Cmax	up to 504 hours post dose	Highest observed plasma concentration of JAB-21822
JAB-21822 PK: MRT	up to 504 hours post dose	Mean residence time of JAB-21822
Number of participants with adverse events	up to 504 hours post dose	All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms and ophthalmological assessments

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China