Healthy SubjectsPhase 1NCT05802810
The Mass Balance Study of [14C]JT001
A Phase 1 study testing [14C]JT001 in people with Healthy Subjects, run by Shanghai Vinnerna Biosciences Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- [14C]JT001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2023to 27 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: 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.
- Conditions
- Healthy Subjects
- Being tested
- [14C]JT001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]JT001Drug
Subjects will receive approximately 300 mg/100 µCi of [14C]JT001 orally.
| Study group | Role | What they receive |
|---|---|---|
| [14C]JT001 | Experimental | Not described Receives: Drug: [14C]JT001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactive recovery
The percentage of radioactivity recovered from collected samples
Measured: 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
Measured: 1 month
Peak concentration（Cmax）
The highest plasma drug concentration that can be achieved after medication
Measured: 1 month
time to peak（Tmax）
After a single dose, the time of peak blood concentration
Measured: 1 month
elimination half life（t1/2）
the time it takes the blood to reduce the concentration of the drug to half
Measured: 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)
Measured: 1 month
Secondary outcomes (1)
Adverse events (AEs)
Number of cases and incidence of adverse events(AEs)
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start18 Mar 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802810
- Sponsor's protocol ID
- JT016-001-I
- Status last verified
- Jun 2025
- First submitted
- 17 Feb 2023
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mass Balance Study of [14C]JT001 in Chinese Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT05802810
- Acronym / sponsor ID
- JT016-001-I
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| [14C]JT001 | Experimental | Drug: [14C]JT001 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]JT001Subjects will receive approximately 300 mg/100 µCi of [14C]JT001 orally. | Drug | [14C]JT001 |
Primary outcome
Total radioactive recovery
Time frame: 1 month
The percentage of radioactivity recovered from collected samples
cumulative excretion rate of total radioactive material in fecal matter
Time frame: 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
Peak concentration（Cmax）
Time frame: 1 month
The highest plasma drug concentration that can be achieved after medication
time to peak（Tmax）
Time frame: 1 month
After a single dose, the time of peak blood concentration
elimination half life（t1/2）
Time frame: 1 month
the time it takes the blood to reduce the concentration of the drug to half
Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS)
Time frame: 1 month
The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS)
1 secondary outcome
Adverse events (AEs)
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]JT001 in people with Healthy Subjects, run by Shanghai Vinnerna Biosciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radioactive recovery (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.