Mass Balance Study of [14C]JAB-21822

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

• [14C]JAB-21822 (Drug): Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach

Primary outcomes

• 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
• 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: t1/2 [up to 504 hours post dose]: Elimination half-life
• Total radioactivity in plasma PK: MRT [up to 504 hours post dose]: Mean residence time
• Total radioactivity in plasma PK: Tmax [up to 504 hours post dose]: Time for Cmax
• 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
• Whole blood to plasma total radioactivity ratio [up to 504 hours post dose]

Secondary outcomes

• JAB-21822 PK: Cmax [up to 504 hours post dose]: Highest observed plasma concentration 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: MRT [up to 504 hours post dose]: Mean residence time of JAB-21822
• JAB-21822 PK: Tmax [up to 504 hours post dose]: Time for Cmax 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

Sex: Male, ages: 18 Years to 45 Years, accepts healthy volunteers

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.

• Miao Liyan doctor of pharmacy, Principal investigator, The First Affiliated Hospital of Soochow University