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

NCT07293390 | Completed Phase 1

• 1 other identifier: TQ05105-I-05
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (3)

• loss rate

  Total radioactive recovery rate and cumulative total radioactive recovery rate in excreta (urine and feces) for each time interval.

  From 24 hours prior to administration to 504 hours post-administration

• Peak concentration (Cmax)

  Maximum plasma drug concentration

  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

  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

  From before the first administration to 7 days after the administration

Study Arms (1)

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.

Drug: TQ05105

Interventions

TQ05105 DRUG

Janus Kinase 2 (JAK2) inhibitor

TQ05105

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.);

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Jiangnan University Affiliated Hospital

Wuxi, Jiangsu, 214122, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: March 18, 2024
• Primary Completion: April 8, 2024
• Study Completion: August 20, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CN (1)