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

NCT06591845 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

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

Sponsors & Collaborators

  • Shanghai Ark Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • David Han, M.D., M.P.H · California Clinical Trials Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06591845 on ClinicalTrials.gov