QT Interval/Corrected QT Interval （QT/QTc） Clinical Study to Evaluate the Cardiac Safety of TQ05105 Tablets in Healthy Participants

NCT07708272 | Active Not Recruiting Phase 1

• 1 other identifier: TQ05105-I-10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To evaluate the effect of single-dose TQ05105 on QTcF interval in healthy Chinese participants. Secondary Objectives: To evaluate the effects of single-dose TQ05105 on other cardiac parameters (heart rate, QT, RR, PR and QRS intervals) in healthy Chinese participants; To verify assay sensitivity by evaluating the effect of moxifloxacin on QTcF interval; To evaluate the safety and tolerability of single-dose TQ05105 in healthy Chinese participants; To characterize the pharmacokinetic (PK) characteristics of TQ05105 and its metabolite (TQ12550) after single administration of TQ05105 tablets in healthy Chinese participants.

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• Fridericia Placebo-Corrected Change from Baseline in QTc Interval (ΔΔQTcF)

  Placebo \& baseline corrected ΔQTcF, core indicator to assess drug effect on ventricular repolarization.

  60 minutes, 45 minutes and 30 minutes before dosing on Day 1 of each period, and 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.

Secondary Outcomes (15)

• Heart Rate (HR)

  60 minutes, 45 minutes and 30 minutes before dosing on Day 1 of each period, and 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.

• PR interval (PR)

  60 minutes, 45 minutes and 30 minutes before dosing on Day 1 of each period, and 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.

• RR interval (RR)

  60 minutes, 45 minutes and 30 minutes before dosing on Day 1 of each period, and 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.

• Peak concentration (Cmax)

  1 hours before dosing, and at 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.

• Area under the plasma concentration-time curve ( AUC0-t)

  1 hours before dosing, and at 15 minutes, 30 minutes, 1 hours, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after dosing.

Study Arms (4)

TQ05105 tablets 20 mg+Placebo tablets 10 mg

EXPERIMENTAL

4 tablets of 5 mg TQ05105 tablets plus 2 tablets of 5 mg matching placebo tablets, delivering a total TQ05105 dose of 20 mg.

Drug: TQ05105 tablets; Drug: Placebo tablets

TQ05105 tablets 30 mg

EXPERIMENTAL

6 tablets of 5 mg TQ05105 tablets, with a total TQ05105 dose of 30 mg.

Drug: TQ05105 tablets

Placebo tablets 30 mg

PLACEBO COMPARATOR

6 tablets of 5 mg TQ05105 matching placebo tablets, with a total placebo dose of 30 mg.

Drug: Placebo tablets

Moxifloxacin Hydrochloride tablets 0.4 g

ACTIVE COMPARATOR

1 tablet of 0.4 g Moxifloxacin Hydrochloride Tablets, serving as an open-label positive control drug.

Drug: Moxifloxacin Hydrochloride Tablets

Interventions

Placebo tablets DRUG

Placebo tablets contain no active substance.

Placebo tablets 30 mg; TQ05105 tablets 20 mg+Placebo tablets 10 mg

Moxifloxacin Hydrochloride Tablets DRUG

Moxifloxacin Hydrochloride Tablets serve as positive control drug.

Moxifloxacin Hydrochloride tablets 0.4 g

TQ05105 tablets DRUG

TQ05105 tablets are Janus kinase (JAK) inhibitors.

TQ05105 tablets 20 mg+Placebo tablets 10 mg; TQ05105 tablets 30 mg

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate in the clinical trial and sign the informed consent form; fully understand the trial content, procedures and potential adverse reactions; able to communicate well with the investigator and complete the study in accordance with the protocol requirements;
• Participants (including their partners) have no plans for pregnancy, sperm donation or egg donation from screening until 6 months after the last dose of study drug, and voluntarily adopt effective contraceptive measures;
• Healthy participants aged 18 to 45 years (inclusive) at the time of signing the informed consent form, both male and female eligible;
• At screening, male participants weigh no less than 50.0 kg and female participants weigh no less than 45.0 kg. Body mass index (BMI) = weight (kg) / height² (m²), within the range of 18.0 to 26.0 kg/m² (inclusive).

You may not qualify if:

• History of severe or chronic diseases of the circulatory, digestive, respiratory, urinary, nervous, hematological, endocrine and metabolic, neoplastic, immune or psychiatric systems or any other medical conditions that may interfere with trial outcomes within the past 1 year or at present;
• History of any malignancy within 5 years before screening;
• Platelet count or absolute neutrophil count below the lower limit of the reference range in complete blood count at screening;
• Any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
• Subjects with any condition that may affect the absorption, distribution, metabolism or excretion of the study drug (e.g., inability to swallow tablets) or who have undergone gastrointestinal resection that may interfere with drug absorption, distribution, metabolism or excretion;
• Risk factors for torsades de pointes (TdP) at screening, including but not limited to the history of: syncope of unknown origin; heart failure; myocardial infarction; angina pectoris; history of various electrolyte abnormalities (potassium, sodium, chloride, calcium, magnesium, etc.); bundle branch block; atrial fibrillation, atrial flutter, atrial premature beats, ventricular premature beats, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormality; personal or family history of long QT syndrome (LQTS); or family history of sudden cardiac death;
• Hypersensitivity to moxifloxacin or any fluoroquinolone antibacterial agents, TQ05105 or its excipients, or history of multiple allergies (e.g., allergy to two or more substances, including drug allergy history, predisposition to skin rash, eczema, urticaria, asthma, etc.);
• Use of any strong or moderate inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 enzymes within 4 weeks before screening (see Appendix 3 for details);
• Use of any prescription drugs (including that may cause QT/QTc interval prolongation / TdP), over-the-counter drugs, Chinese herbal medicines or dietary supplements (e.g., vitamins, calcium supplements, etc.) within 4 weeks before screening;
• Participation in any drug clinical trial and exposure to any investigational product within 3 months before screening or within 5 half-lives of the drug (whichever is longer);
• Abnormal results of physical examination, vital signs, clinical laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis), chest radiograph (PA and lateral views), or abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidneys) at screening that are judged clinically significant by the investigator;
• lead ECG exceeding the following thresholds at screening or baseline: PR \> 200 ms, QRS \> 110 ms, HR \< 50 bpm or \> 100 bpm, QTcF \> 450 ms (for both males and females); or ECG abnormalities judged by the investigator to be clinically significant (e.g., atrioventricular block, torsades de pointes, other types of ventricular tachycardia, ventricular fibrillation and ventricular flutter, clinically significant T-wave changes, or any 12-lead ECG abnormalities that may affect the QTc interval);
• Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody;
• Glomerular filtration rate (eGFR) \< 90 mL/min/1.73m² at screening;
• Average daily cigarette consumption of more than 5 cigarettes within 3 months before screening;

Sponsors & Collaborators

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

Study Sites (1)

PKU Care Luzhong Hospital

Zibo, Shandong, 255499, China

Location

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

CN (1)