drugset / Trial / NCT07708272
QT Interval/Corrected QT Interval (QT/QTc) Clinical Study to Evaluate the Cardiac Safety of TQ05105 Tablets in Healthy Participants
RandomizedCrossoverTriple-blindOther
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.
Timeline
- Start
- 2026-07
- Primary completion
- 2026-12
- Completion
- 2027-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Moxifloxacin | Small molecule | 0.4 g | — |
| Subject | TQ05105 | Small molecule | 20 mg | — |
| Subject | TQ05105 | Small molecule | 30 mg | — |