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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07708272
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • TQ05105 tablets — DRUG
    TQ05105 tablets are Janus kinase (JAK) inhibitors.
  • Placebo tablets — DRUG
    Placebo tablets contain no active substance.
  • Moxifloxacin Hydrochloride Tablets — DRUG
    Moxifloxacin Hydrochloride Tablets serve as positive control drug.

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: TQ05105 tablets 20 mg+Placebo tablets 10 mg
    4 tablets of 5 mg TQ05105 tablets plus 2 tablets of 5 mg matching placebo tablets, delivering a total TQ05105 dose of 20 mg.
  • Experimental: TQ05105 tablets 30 mg
    6 tablets of 5 mg TQ05105 tablets, with a total TQ05105 dose of 30 mg.
  • Placebo Comparator: Placebo tablets 30 mg
    6 tablets of 5 mg TQ05105 matching placebo tablets, with a total placebo dose of 30 mg.
  • Active Comparator: Moxifloxacin Hydrochloride tablets 0.4 g
    1 tablet of 0.4 g Moxifloxacin Hydrochloride Tablets, serving as an open-label positive control drug.

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. ]

Central Contacts

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