Mass Balance Study of [14C]JAB-21822

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

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

Study Overview

• Status: Completed
• Conditions: Mass Balance Study in Healthy Subjects
• Intervention / Treatment: Drug: [14C]JAB-21822

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]JAB-21822; Single oral dose of 800mg 14C]JAB-2182 suspension	Drug: [14C]JAB-21822; Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
JAB-21822 PK: Cmax	Highest observed plasma concentration of JAB-21822	up to 504 hours post dose
JAB-21822 PK: Area under the curve	Area under the plasma concentration time curve of JAB-21822	up to 504 hours post dose
JAB-21822 PK: t1/2	Elimination half-life of JAB-21822	up to 504 hours post dose
JAB-21822 PK: MRT	Mean residence time of JAB-21822	up to 504 hours post dose
JAB-21822 PK: Tmax	Time for Cmax of JAB-21822	up to 504 hours post dose
Number of participants with adverse events	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	up to 504 hours post dose

Collaborators and Investigators

• Sponsor: Jacobio Pharmaceuticals Co., Ltd.
• Investigators: Study Director: Jacobio Pharmaceuticals, Jacobio Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2023
• Primary Completion (Actual): August 9, 2023
• Study Completion (Actual): August 9, 2023

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 25, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: JAB-21822-1008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No