Mass Balance Study of [14C]JAB-21822

Phase 1CompletedNCT05920941

Allist Pharmaceuticals, Inc.6 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Mass Balance Study in Healthy Subjects

Interventions

[14C]JAB-21822DRUG

Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China