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NOT YET RECRUITING
NCT06591845
PHASE1

Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects

Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a single-center, randomized, partially double-blind, placebo and active-controlled, 4-period crossover design thorough QT/QTc (TQT) clinical study to evaluate the effects of ziresovir on cardiac repolarization in healthy subjects.

Official title: A Single-Center, Randomized, Partially Double-Blind, Placebo- and Active-Controlled, Four-period Crossover, Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2024-09-15

Completion Date

2024-12-31

Last Updated

2024-09-19

Healthy Volunteers

Yes

Interventions

DRUG

Ziresovir 125 mg

Active Substance: Ziresovir, Pharmaceutical Form: Suspension, Route of Administration: Oral

DRUG

Ziresovir 500 mg

Active Substance: Ziresovir, Pharmaceutical Form: Suspension, Route of Administration: Oral

DRUG

Placebo

Active Substance: Placebo, Pharmaceutical Form: Suspension, Route of Administration: Oral

DRUG

Moxifloxacin hydrochloride tablet 400 mg

Active Substance: Moxifloxacin hydrochloride Pharmaceutical Form: Tablet Route of Administration: Oral