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NOT YET RECRUITING
NCT07708272
PHASE1

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.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-07

Completion Date

2027-02

Last Updated

2026-07-16

Healthy Volunteers

Yes

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.

Locations (1)

PKU Care Luzhong Hospital

Zibo, Shandong, China