QT Interval/Corrected QT Interval (QT/QTc) Clinical Study to Evaluate the Cardiac Safety of TQ05105 Tablets in Healthy Participants
NCT07708272 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-08-07
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
Interventions
- DRUG
-
TQ05105 tablets
TQ05105 tablets are Janus kinase (JAK) inhibitors.
- DRUG
-
Placebo tablets
Placebo tablets contain no active substance.
- DRUG
-
Moxifloxacin Hydrochloride Tablets
Moxifloxacin Hydrochloride Tablets serve as positive control drug.
Sponsors & Collaborators
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-07-30
- Primary Completion
- 2026-12-31
- Completion
- 2027-02-28
Countries
- China
Study Locations
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