NCT06591845

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This clinical study is a single-center, randomized, partially double-blind, placebo- and active-controlled, four-period crossover design, with healthy subjects comprising the enrolled population. Ziresovir and placebo will be administered in a double-blind manner, while moxifloxacin hydrochloride tablets will be administered in as open-label. Thirty-two subjects meeting all inclusion criteria and none of the exclusion criteria will be randomized into 1 of 12 dosing sequences, each consisting of 4 periods with an 8-day washout period in-between.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-09-19
• Last updated: 2024-09-19

Regulatory

• FDA-regulated drug study