The Mass Balance Study of [14C]JT001

The Mass Balance Study of [14C]JT001 in Chinese Healthy Adult Male Subjects

This study is a single center, single dose, non-randomized, open design clinical study.By quantitative analysis of the biological samples of subjects after oral administration of [14C]JT001, the data of human radioactive excretion rate and the main excretion pathway will be obtained. The main metabolites ,metabolic pathways and elimination pathways of JT001 will be identified.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: [14C]JT001

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • the First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult males
2. Age: 18-45 years old
3. Body weight: Body mass index (BMI) is between 19.0 and 26.0 kg/m2 (including boundary values), and the body weight of the subject is not less than 50.0 kg;
4. Voluntarily sign informed consent;
5. Subjects were able to complete the trail according to protocol.

Exclusion Criteria:

1. Physical examination, vital signs, routine laboratory examination, imaging examination abnormal and clinically significant
2. The electrocardiogram was abnormal and was considered clinically significant by the investigators, or has a history of organic heart disease
3. Has hepatitis B (HBV) or hepatitis C (HCV) or HIV antibody and syphilis antibody positive;
4. Any drug that inhibits or induces the drug transporters P-gp and BCRP has been used within 30 days prior to the screening period
5. Any conditions that may affect drug absorption.
6. Previous antineoplastic therapy meets washout requirements.
7. Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease
8. Habitual constipation or diarrhea.
9. Significant radioactive exposure within 1 year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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]JT001	Drug: [14C]JT001; Subjects will receive approximately 300 mg/100 µCi of [14C]JT001 orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total radioactive recovery	The percentage of radioactivity recovered from collected samples	1 month
cumulative excretion rate of total radioactive material in fecal matter	After oral administration of the drug, the subjects collected feces for 10 Days to obtain the excretion of accumulated radioactive substances in feces	1 month
Peak concentration（Cmax）	The highest plasma drug concentration that can be achieved after medication	1 month
time to peak（Tmax）	After a single dose, the time of peak blood concentration	1 month
elimination half life（t1/2）	the time it takes the blood to reduce the concentration of the drug to half	1 month
Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS)	The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Number of cases and incidence of adverse events(AEs)	2 month

Collaborators and Investigators

• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
• Collaborators: Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2023
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: JT016-001-I

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