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MyelofibrosisPhase 1NCT07708272

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

A Phase 1 study testing TQ05105 tablets and Moxifloxacin Hydrochloride Tablets in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Myelofibrosis
What is being tested?
TQ05105 tablets and Moxifloxacin Hydrochloride Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
30 Jul 2026to Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • 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).

Who cannot join

  • 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;
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  • 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;
  • 12-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;
  • History of substance abuse within 3 months before screening, or positive urine drug screen;
  • Regular alcohol consumption within 3 months before screening, defined as more than 14 standard alcohol units per week (1 unit = 360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine), or positive breath alcohol test;
  • Blood donation or blood loss ≥ 200 mL, or plasmapheresis within 4 weeks before screening;
  • Consumption of any food or beverage containing alcohol (or positive breath alcohol test), grapefruit juice, coffee, tea, cola, or chocolate within 72 hours before dosing;
  • Pregnant or lactating female participants, or positive blood pregnancy test or value above the upper limit of normal, or female participants of childbearing potential who have had unprotected sexual intercourse within 2 weeks before screening;
  • Strenuous exercise (e.g., marathon, weightlifting) within 2 weeks before screening;
  • Any other condition considered by the investigator to make the participant unsuitable for the trial;
  • Participants unable to complete the trial due to personal reasons.

Trial locations and contacts

1 site in 1 country.

China1 site
  • PKU Care Luzhong Hospital

    Zibo, Shandong, 255499

Other trials in China

About this study

Official title: A Randomized, Double-Blind (Except Moxifloxacin), Placebo and Positive-Controlled, Four-Period Crossover Thorough QT/QTc Clinical Study to Evaluate the Cardiac Safety of TQ05105 Tablets in Healthy Participants

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
Being tested
TQ05105 tablets, Placebo tablets, Moxifloxacin Hydrochloride Tablets
Medical subject headings
Primary Myelofibrosis

What participants receive

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

  • TQ05105 tabletsDrug

    TQ05105 tablets are Janus kinase (JAK) inhibitors.

  • Placebo tabletsDrug

    Placebo tablets contain no active substance.

  • Moxifloxacin Hydrochloride TabletsDrug

    Moxifloxacin Hydrochloride Tablets serve as positive control drug.

Study groups in NCT07708272
Study groupRoleWhat they receive
TQ05105 tablets 20 mg+Placebo tablets 10 mgExperimental4 tablets of 5 mg TQ05105 tablets plus 2 tablets of 5 mg matching placebo tablets, delivering a total TQ05105 dose of 20 mg.
Receives: Drug: TQ05105 tablets; Drug: Placebo tablets
TQ05105 tablets 30 mgExperimental6 tablets of 5 mg TQ05105 tablets, with a total TQ05105 dose of 30 mg.
Receives: Drug: TQ05105 tablets
Placebo tablets 30 mgPlacebo comparator6 tablets of 5 mg TQ05105 matching placebo tablets, with a total placebo dose of 30 mg.
Receives: Drug: Placebo tablets
Moxifloxacin Hydrochloride tablets 0.4 gActive comparator1 tablet of 0.4 g Moxifloxacin Hydrochloride Tablets, serving as an open-label positive control drug.
Receives: Drug: Moxifloxacin Hydrochloride Tablets

What is being measured

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

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

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

    Measured: 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)
  1. Heart Rate (HR)

    Holter-derived heart rate

    Measured: 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.

  2. PR interval (PR)

    PR interval obtained via continuous Holter ECG monitoring

    Measured: 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.

  3. RR interval (RR)

    Holter-recorded RR interval

    Measured: 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.

  4. Peak concentration (Cmax)

    Maximum plasma drug concentration

    Measured: 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.

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

    The area enclosed by the blood concentration curve to the timeline

    Measured: 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.

  6. Plasma clearance (CL/F)

    How much of the plasma is cleared per unit of time

    Measured: 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.

  7. Plasma elimination half-life (t1/2)

    The time it takes for the terminal phase blood concentration to drop by half

    Measured: 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.

  8. Adverse event rate

    The occurrence of all adverse events (AEs), and serious adverse events (SAEs).

    Measured: 26 days after the first dose

  9. Hematology

    Abnormal hematology

    Measured: 26 days after the first dose

  10. Serum biochemistry

    Abnormal serum biochemistry

    Measured: 26 days after the first dose

  11. Coagulation

    Abnormal coagulation

    Measured: 26 days after the first dose

  12. Urinalysis

    Abnormal urinalysis

    Measured: 26 days after the first dose

  13. Blood pressure

    Abnormal blood pressure

    Measured: 26 days after the first dose

  14. Pulse

    Abnormal pulse

    Measured: 26 days after the first dose

  15. Body temperature

    Abnormal body temperature

    Measured: 26 days after the first dose

Timeline

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

  1. First posted16 Jul 2026
  2. Study start30 Jul 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07708272
Sponsor's protocol ID
TQ05105-I-10
Status last verified
Aug 2026
First submitted
13 Jul 2026
Last updated
7 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQ05105 tablets and Moxifloxacin Hydrochloride Tablets in people with Myelofibrosis, 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 4 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Fridericia Placebo-Corrected Change from Baseline in QTc Interval (ΔΔQTcF) (time frame: 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.). 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 7 Aug 2026.

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