drugset / Trial / NCT07708272

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

NCT07708272

Phase 1 Not yet recruiting 60 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Comparator Moxifloxacin Small molecule 0.4 g
Subject TQ05105 Small molecule 20 mg
Subject TQ05105 Small molecule 30 mg

Indications