Mass Balance Study of [14C]JAB-21822

NCT05920941 | Completed Phase 1

• 1 other identifier: JAB-21822-1008
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mass Balance Study in Healthy Subjects

Outcome Measures

Primary Outcomes (8)

• Recovery of total radioactivity in urine and fecal samples

  Mass balance recovery of total radioactivity in urine and fecal samples

  up to 504 hours post dose

• Total radioactivity in plasma PK: Cmax

  Highest radioactivity observed plasma concentration

  up to 504 hours post dose

• Total radioactivity in plasma PK: Area under the curve

  Area under the plasma concentration time curve

  up to 504 hours post dose

• Total radioactivity in plasma PK: t1/2

  Elimination half-life

  up to 504 hours post dose

• Total radioactivity in plasma PK: MRT

  Mean residence time

  up to 504 hours post dose

• Total radioactivity in plasma PK: Tmax

  Time for Cmax

  up to 504 hours post dose

• Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples

  Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites

  up to 504 hours post dose

• Whole blood to plasma total radioactivity ratio

  up to 504 hours post dose

Secondary Outcomes (6)

• JAB-21822 PK: Cmax

  up to 504 hours post dose

• JAB-21822 PK: Area under the curve

  up to 504 hours post dose

• JAB-21822 PK: t1/2

  up to 504 hours post dose

• JAB-21822 PK: MRT

  up to 504 hours post dose

• JAB-21822 PK: Tmax

  up to 504 hours post dose

Study Arms (1)

[14C]JAB-21822

EXPERIMENTAL

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

Drug: [14C]JAB-21822

Interventions

[14C]JAB-21822 DRUG

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

[14C]JAB-21822

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Allist Pharmaceuticals, Inc.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Study Officials

• Miao Liyan doctor of pharmacy

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 27, 2023
• Study Start: July 8, 2023
• Primary Completion: August 9, 2023
• Study Completion: August 9, 2023
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)