The Mass Balance Study of [14C]JT001

• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05802810
• Collaborator: Sponsor GmbH (Other)
• Enrollment: 6
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 6.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: [14C]JT001	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single GroupSingle Group
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Mass Balance Study of [14C]JT001 in Chinese Healthy Adult Male Subjects
• Actual Study Start Date: Mar 18, 2023
• Anticipated Primary Completion Date: Jun 15, 2023
• Anticipated Study Completion Date: Oct 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [14C]JT001	Drug: [14C]JT001; Subjects will receive approximately 300 mg/100 µCi of [14C]JT001 orally.

Outcome Measures

Primary Outcome Measures

1. Total radioactive recovery [1 month]

   The percentage of radioactivity recovered from collected samples

2. cumulative excretion rate of total radioactive material in fecal matter [1 month]

   After oral administration of the drug, the subjects collected feces for 10 Days to obtain the excretion of accumulated radioactive substances in feces

3. Peak concentration（Cmax） [1 month]

   The highest plasma drug concentration that can be achieved after medication

4. time to peak（Tmax） [1 month]

   After a single dose, the time of peak blood concentration

5. elimination half life（t1/2） [1 month]

   the time it takes the blood to reduce the concentration of the drug to half

6. Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS) [1 month]

   The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS)

Secondary Outcome Measures

1. Adverse events (AEs) [2 month]

   Number of cases and incidence of adverse events(AEs)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Vinnerna Biosciences Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05802810
• Other Study ID Numbers: JT016-001-I
• First Posted: Apr 7, 2023
• Last Update Posted: Apr 7, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 7, 2023