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Healthy Chinese SubjectsPhase 1NCT06832540

Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects

A Phase 1 study testing [14C]TJ0113 in people with Healthy Chinese Subjects, run by Hangzhou PhecdaMed Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects 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 Chinese Subjects
What is being tested?
[14C]TJ0113
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
19 Feb 2025to 5 Mar 2025
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 Chinese males;
  • Age at informed consent: 18-45 years (inclusive);
  • Body mass index (BMI) ranging from 19 to 26 kg/m2 (inclusive) and body weight ≥ 50 kg;
  • Fully understand the objectives and requirements of this study, and voluntarily sign the informed consent form;
  • Able to communicate well with study personnel and complete the study according to the protocol.

Who cannot join

  • Auxiliary examination:
  • Subjects who have abnormal and clinically significant results of comprehensive physical examination, digital anal examination, laboratory tests (hematology, blood chemistry, coagulation function, urinalysis, stool routine + occult blood, thyroid function), 12-lead ECG, ophthalmic examination (slit-lamp, intraocular pressure and fundus radiography), chest X-ray (anteroposterior) and abdominal B ultrasound (liver, gallbladder, pancreas, spleen and kidney);
  • Subjects with unqualified vital signs that remain unqualified upon retesting;
  • Subjects who have a resting corrected QT interval (QTcF) > 450 ms (corrected according to Fridericia's formula) or QRS > 120 ms as determined by 12-lead electrocardiogram (ECG), or a previous history of long QT syndrome;
  • Subjects who have any clinically significant abnormality in hepatitis B surface antigen, hepatitis B E antigen, hepatitis C virus antibody (anti-HCV), treponema pallidum antibody test, and human immunodeficiency virus antibody (anti-HIV) as judged by the investigator;
  • Medication History:
Show all 32Show fewer
  • Subjects who use any drug inhibiting or inducing hepatic drug-metabolizing enzyme activity (see Appendix 1 for details) within 30 days before screening;
  • Subjects who use any prescription drugs, over-the-counter drugs, Chinese herbal medicines and food supplements (such as vitamins and calcium supplements) from 14 days before screening to predose;
  • Disease and Surgical History:
  • Subjects who have febrile illness or active infection within 14 days before screening;
  • Subjects who have gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea or malabsorption syndrome, or a history of severe vomiting or diarrhea within one week before screening;
  • Subjects who have a history of any clinically significant disease or any disease or condition that may affect the study results in the opinion of the investigator, including but not limited to cardiovascular system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases;
  • Subjects who have dysphagia or any condition that may affect oral administration and drug absorption (e.g., cholecystectomy, gastric bypass, duodenotomy, colectomy, post-gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, intestinal obstruction, etc.);
  • Subjects who have undergone major surgery within 6 months before screening or have incomplete healing of surgical incision, including but not limited to any surgery with significant bleeding risk, prolonged general anesthesia, or incisional biopsy or significant traumatic injury; or who have undergone surgery affecting drug absorption, distribution, metabolism, excretion, or plan to undergo surgery during the study period;
  • Subjects who have drug, environmental, food allergy or allergic constitution, or may be allergic to the investigational product judged by the investigator;
  • Subjects who have hemorrhoids or perianal diseases accompanied by regular/ongoing hematochezia, irritable bowel syndrome, inflammatory bowel disease;
  • Life Style:
  • Habitual constipation or diarrhea;
  • Subjects who have alcoholism or regular drink within 6 months before screening, defined as drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits 40% or 150 mL of wine), or have a breathalyzer test result > 0 mg/100 ml at screening, or unable to abstain from alcohol during the study;
  • Subjects who smoke more than 5 cigarettes per day or habitually use nicotine-containing products within 3 months before screening, or inability to abstain during the study;
  • Subjects who abuse drugs or use soft drugs (such as marijuana) 3 months before screening or take hard drugs (such as amphetamines, phencyclidine, etc.) 1 year before screening; or have positive urine drug test during screening;
  • Subjects who have special requirements for diet or fail to follow the standard diet (such as intolerant of standard meals); habitually drink grapefruit juice or excessive tea, coffee and/or caffeine beverages, or unable to abstain during the study; refuse to discontinue any beverages containing xanthine derivatives, such as caffeine (coffee, tea, cola, chocolate, etc.) from 48 hours pre-dose until the end of the study; refuse to discontinue animals' viscera, seafood, soy products and other foods containing high purine;
  • Subjects who have strenuous exercise or other factors affecting drug absorption, distribution, metabolism and excretion;
  • Lactose intolerance (subjects who have had diarrhea from drinking milk);
  • Others:
  • Subjects who are exposed to radioactivity for a prolonged period, or have significant radiation exposure (≥ 2 chest/abdominal CT scans, or ≥ 3 other X-ray examinations) within one year before screening, or have participated in radiopharmaceutical labeling trials within one year before screening;
  • Subjects who have a history of syncope due to the needles or blood, or difficult blood collection or cannot tolerate venipuncture for blood collection;
  • Subjects who have participated in any clinical trial within 3 months before screening and have received an investigational product or used an investigational device; or those who plan to participate in other clinical trials during this study, or subjects who do not participate in the clinical trial in person;
  • Subjects who have been vaccinated within 1 month before screening or planned to receive vaccination during the study;
  • Subjects who plan to father a child or donate sperm from the time of signing the informed consent form to 1 year after completing the study, or do not agree to take strict contraceptive measures (see Appendix 3 for details) for themselves and their spouses from the time of signing the informed consent form to 1 year after completing the study;
  • Subjects who have blood loss or blood donation ≥ 400 mL within 3 months before screening, or blood transfusion or blood component within 1 month before screening, or blood donor during planned medication and within 3 months after discontinuation;
  • Subjects who have any other factor that the investigator considers inappropriate for participation in this study or the subject withdraws from the study for his/her own reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu

Other trials in China

About this study

Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects

Read the detailed description

This is a single-center, single-dose and open-label trial designed to enroll 6-8 healthy adult male subjects to evaluate the mass balance of [14C]TJ0113 in these subjects. Each subject will receive a single oral dose of approximately 200 mg /100 μCi [14C]TJ0113 oral formulation; after administration, blood, urine, and stool samples will be collected at specified time points/intervals during the study. The total radioactivity in whole blood and plasma, as well as the plasma concentrations of TJ0113 and its metabolites will be determined to calculate the pharmacokinetic (PK) parameters of [14C]TJ0113 and its metabolites in plasma and whole blood as well as the PK parameters of TJ0113 and its metabolites in plasma, and to understand the distribution of total radioactivity in whole blood and plasma; the radioactivity in urine and feces will be determined to obtain the data on total recovery, excretion and main routes of excretion; the metabolic pathways of TJ0113 in humans will be determined through radiolabeled metabolite profiling and structural identification of major metabolites in plasma, urine, and feces.

Being tested
[14C]TJ0113

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]TJ0113Drug

    Subjects will receive a single oral dose of approximately 200 mg/100 μCi of the oral formulation of [14C] TJ0113 under fasted conditions.

Study groups in NCT06832540
Study groupRoleWhat they receive
[14C]TJ0113ExperimentalA single oral dose of approximately 200 mg/100 μCi of the oral formulation of [14C] TJ0113
Receives: Drug: [14C]TJ0113

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The excretion ratio of total radioactivity at each time interval and the cumulative recovery of total radioactivity in urine and feces

    The excretion ratio of total radioactivity at each time interval and the cumulative recovery of total radioactivity in urine and feces

    Measured: Predose up to 240 hours after administration of [14C]TJ0113

  2. Pharmacokinetic parameters of total radioactivity in plasma: Cmax

    Maximum concentration

    Measured: Predose up to 168 hours after administration of [14C]TJ0113

  3. Pharmacokinetic parameters of total radioactivity in plasma: Tmax

    Time to Maximum Concentration

    Measured: Predose up to 168 hours after administration of [14C]TJ0113

  4. Pharmacokinetic parameters of total radioactivity in plasma: t1/2

    Half Life

    Measured: Predose up to 168 hours after administration of [14C]TJ0113

  5. Pharmacokinetic parameters of total radioactivity in plasma: MRT

    Mean Residence Time

    Measured: Predose up to 168 hours after administration of [14C]TJ0113

  6. Pharmacokinetic parameters of total radioactivity in plasma: AUC

    Area Under the Plasma Concentration-time Curve

    Measured: Predose up to 168 hours after administration of [14C]TJ0113

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start19 Feb 2025
  3. Primary completion5 Mar 2025
  4. Study completion5 Mar 2025

Resources

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
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06832540
Sponsor's protocol ID
TJJS01-002
Status last verified
Nov 2025
First submitted
6 Feb 2025
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]TJ0113 in people with Healthy Chinese Subjects, run by Hangzhou PhecdaMed 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 32 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 17 Nov 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?

The excretion ratio of total radioactivity at each time interval and the cumulative recovery of total radioactivity in urine and feces (time frame: Predose up to 240 hours after administration of [14C]TJ0113). 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?

On the ClinicalTrials.gov record for NCT06832540.

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 17 Nov 2025.

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