Mass Balance Study of [14C]JAB-21822

NCT ID: NCT05920941

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-08

Study Completion Date

2023-08-09

Brief Summary

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

Detailed Description

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

Conditions

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Mass Balance Study in Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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[14C]JAB-21822

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

Group Type EXPERIMENTAL

[14C]JAB-21822

Intervention Type DRUG

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

Interventions

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[14C]JAB-21822

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Allist Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miao Liyan doctor of pharmacy

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

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The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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JAB-21822-1008

Identifier Type: -

Identifier Source: org_study_id

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