Mass Balance of [14C] TQ05105 in Healthy Chinese SubjectsPhase 1NCT07293390

A Clinical Trial of Mass Balance of [14C] TQ05105 in Healthy Chinese Subjects

A Phase 1 study testing TQ05105 in people with Mass Balance of [14C] TQ05105 in Healthy Chinese Subjects, run by Chia Tai Tianqing Pharmaceutical Group 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

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Mass Balance of [14C] TQ05105 in Healthy Chinese Subjects
What is being tested?: TQ05105
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 18 Mar 2024to 20 Aug 2024
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male;
Age: 18-45 years (inclusive);
Body weight: Body mass index (BMI) between 19-26 kg/m² (inclusive), with a minimum body weight of 50 kg;
Voluntarily signs the informed consent form;
The subject is able to communicate well with the investigator and able to complete the trial in accordance with the protocol requirements.

Who cannot join

Abnormalities with clinical significance detected in comprehensive physical examination, routine laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis, fecal routine), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys), etc.;
Abnormal vital signs that remain abnormal upon retesting;
Abnormalities with clinical significance in ophthalmic examinations (slit-lamp, intraocular pressure, and fundus photography);
Positive results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antibody (HIV-Ag/Ab), or syphilis antibody;
Positive nucleic acid test result for Coronavirus Disease 2019 (COVID-19);
Use of any drugs known to inhibit or induce hepatic drug-metabolizing enzymes within 30 days prior to screening (see Appendix 1 for details);

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Use of any prescription drugs, over-the-counter medications, Chinese herbal health products, or dietary supplements (e.g., vitamins, calcium supplements) within 14 days prior to screening;
History or presence of clinically significant diseases affecting the musculoskeletal, neuropsychiatric, endocrine, circulatory, respiratory, digestive, urinary, or reproductive systems, as judged by the investigator;
Any medical condition that increases the risk of elevated blood glucose, such as a history of primary diabetes, steroid-induced diabetes, other secondary diabetes, acute or chronic pancreatitis, deemed clinically significant by the investigator;
History of organic heart disease, heart failure, myocardial infarction, angina, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, atrioventricular block, or long QT syndrome (or related symptoms/family history), deemed clinically significant by the investigator;
History of interstitial lung disease, severely impaired lung function, severe pulmonary fibrosis, radiation pneumonitis, drug-induced lung disease, or evidence of active pulmonary inflammation on screening chest CT, deemed clinically significant by the investigator;
Major surgery within 6 months prior to screening or incomplete wound healing; major surgery includes procedures with significant bleeding risk, prolonged general anesthesia, open biopsy, major traumatic injury, or surgery affecting drug absorption, distribution, metabolism, or excretion; or planned surgery during the study;
History of drug, environmental, or food allergies, allergic constitution, or potential allergy to the investigational drug or its excipients, as judged by the investigator;
Hemorrhoids or perianal diseases with regular/active bleeding, irritable bowel syndrome, or inflammatory bowel disease;
Factors affecting oral administration or drug absorption (e.g., swallowing difficulties, gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, intestinal obstruction, etc.);
Habitual constipation or diarrhea;
Lactose intolerance (history of diarrhea after consuming milk);
Alcohol abuse or regular alcohol consumption within 6 months prior to screening (>14 units per week; 1 unit = 360 mL beer, 45 mL 40% spirits, or 150 mL wine); inability to abstain during the trial, or positive alcohol breath test (>0 mg/100 mL) at screening;
Smoking >5 cigarettes daily within 3 months prior to screening or habitual use of nicotine products, and inability to abstain during the trial;
Drug abuse or use of soft drugs (e.g., marijuana) within 3 months prior to screening, or hard drugs (e.g., cocaine, amphetamines, phencyclidine) within 1 year prior to screening; or positive urine drug screen at screening;
Habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeine-containing beverages, and inability to abstain during the trial;
Occupation involving long-term exposure to radiation conditions; or significant radiation exposure within 1 year prior to the trial (≥2 chest/abdominal CT scans or ≥3 other X-ray examinations); or prior participation in radioactive drug-labeled trials;
History of needle or blood phobia, difficulty with blood collection, or inability to tolerate venipuncture;
Participation in other clinical trials involving investigational drugs or devices within 3 months prior to or during screening, or planned participation during this study; or non-personal participation in clinical trials;
Vaccination within 1 month prior to screening or planned vaccination during the trial;
Plans for reproduction or sperm donation during the trial or within 1 year after completion, or unwillingness to use strict contraception during and within 1 year after the trial (see Appendix 3 for details);
Blood loss or donation ≥400 mL within 3 months prior to screening, or blood transfusion within 1 month prior to screening;
Other reasons deemed by the investigator to make the subject unsuitable for participation, or voluntary withdrawal by the subject.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangnan University Affiliated Hospital
Wuxi, Jiangsu, 214122

Other trials in China

About this study

Official title: Mass Balance Study of TQ05105

To analyze radioactivity excretion and pharmacokinetics in healthy subjects after a single oral dose of [¹⁴C]TQ05105, identifying excretion routes, major metabolites, and biotransformation pathways. Secondary: To determine pharmacokinetics of TQ05105 and metabolites (e.g., TQ12550) via Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and assess treatment safety.

Conditions: Mass Balance of [14C] TQ05105 in Healthy Chinese Subjects
Being tested: TQ05105

What participants receive

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

TQ05105Drug
Janus Kinase 2 (JAK2) inhibitor

Study groups in NCT07293390
Study group	Role	What they receive
TQ05105	Experimental	Take the [14C]TQ05105 suspension under fasting conditions, ensuring the entire dose is administered within 5 minutes. The total water volume used for drug preparation and administration is approximately 240 mL. Receives: Drug: TQ05105

What is being measured

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

loss rate
Total radioactive recovery rate and cumulative total radioactive recovery rate in excreta (urine and feces) for each time interval.
Measured: From 24 hours prior to administration to 504 hours post-administration
Peak concentration (Cmax)
Maximum plasma drug concentration
Measured: Before administration, 0.16, 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration
Area under drug time curve (AUC0-∞)
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time
Measured: Before administration, 0.16, 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration

Secondary outcomes (1)

Adverse event rate
Incidence and severity of adverse events and serious adverse events, and abnormal laboratory examination indicators.
Measured: From before the first administration to 7 days after the administration

Timeline

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

18 Mar 202420 Aug 2024

First posted19 Dec 2025
Study start18 Mar 2024
Primary completion8 Apr 2024
Study completion20 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mass Balance of [14C] TQ05105 in Healthy Chinese SubjectsStudies of the same condition, open and under way.
More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07293390
Sponsor's protocol ID: TQ05105-I-05
Status last verified: Dec 2025
First submitted: 8 Dec 2025
Last updated: 19 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mass Balance Study of TQ05105
ClinicalTrials.gov ID: NCT07293390
Acronym / sponsor ID: TQ05105-I-05
Conditions: Mass Balance of [14C] TQ05105 in Healthy Chinese Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 18 Mar 2024 (actual)
Primary completion: 8 Apr 2024 (actual)
Study completion: 20 Aug 2024 (actual)
First posted: 19 Dec 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TQ05105	Experimental	Drug: TQ05105Take the [14C]TQ05105 suspension under fasting conditions, ensuring the entire dose is administered within 5 minutes. The total water volume used for drug preparation and administration is approximately 240 mL.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy adult male;
Age: 18-45 years (inclusive);
Body weight: Body mass index (BMI) between 19-26 kg/m² (inclusive), with a minimum body weight of 50 kg;
Voluntarily signs the informed consent form;
The subject is able to communicate well with the investigator and able to complete the trial in accordance with the protocol requirements.

Key exclusion criteria (28 listed)

Abnormalities with clinical significance detected in comprehensive physical examination, routine laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis, fecal routine), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys), etc.;
Abnormal vital signs that remain abnormal upon retesting;
Abnormalities with clinical significance in ophthalmic examinations (slit-lamp, intraocular pressure, and fundus photography);
Positive results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antibody (HIV-Ag/Ab), or syphilis antibody;
Positive nucleic acid test result for Coronavirus Disease 2019 (COVID-19);

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
TQ05105Janus Kinase 2 (JAK2) inhibitor	Drug	TQ05105

Primary outcome

loss rate
Time frame: From 24 hours prior to administration to 504 hours post-administration
Total radioactive recovery rate and cumulative total radioactive recovery rate in excreta (urine and feces) for each time interval.
Peak concentration (Cmax)
Time frame: Before administration, 0.16, 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration
Maximum plasma drug concentration
Area under drug time curve (AUC0-∞)
Time frame: Before administration, 0.16, 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time

1 secondary outcome

Adverse event rate
Time frame: From before the first administration to 7 days after the administration

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 19 Dec 2025.

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 TQ05105 in people with Mass Balance of [14C] TQ05105 in Healthy Chinese Subjects, run by Chia Tai Tianqing Pharmaceutical Group 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 28 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 19 Dec 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?

loss rate (time frame: From 24 hours prior to administration to 504 hours post-administration). The study lists 3 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 NCT07293390.

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 19 Dec 2025.