Mass Balance Study of [14C]JAB-21822

Allist Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Mass Balance Study in Healthy Subjects

Treatments: Drug: [14C]JAB-21822

Study type: Interventional

Funder types: Industry

Identifiers

NCT05920941

JAB-21822-1008

Details and patient eligibility

About

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

Full description

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

Enrollment: 6 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

[14C]JAB-21822

Experimental group

Description:

Single oral dose of 800mg 14C\]JAB-2182 suspension

Treatment:

Drug: [14C]JAB-21822