The Mass Balance Study of [14C]JT001

NCT05802810 | Completed Phase 1

• 1 other identifier: JT016-001-I
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Adverse events (AEs)

  2 month

Study Arms (1)

[14C]JT001

EXPERIMENTAL

Drug: [14C]JT001

Interventions

[14C]JT001 DRUG

Subjects will receive approximately 300 mg/100 µCi of \[14C\]JT001 orally.

[14C]JT001

Eligibility Criteria

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

You may qualify if:

• Healthy adult males
• Age: 18-45 years old
• 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;
• Voluntarily sign informed consent;
• Subjects were able to complete the trail according to protocol.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Vinnerna Biosciences Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Study Design

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

Model Details: Single Group

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: April 7, 2023
• Study Start: March 18, 2023
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)