drugset / Trial / NCT07658534

A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.

NCT07658534 ↗

Phase 2/3 Recruiting 290 enrolled Shanghai Ark Biopharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

Respiratory syncytial virus (RSV) is recognized worldwide as a significant pathogen causing lower respiratory tract infection in infants, the elderly, and immunocompromised patients, which may cause bronchiolitis or pneumonia, and affect the cardiovascular system, central nervous system and the renal system, resulting in hospitalization and death risks in children and also high-risk adults, particularly the elderly. The purpose of this study is to evaluate the efficacy of Ziresovir (AK0529) compared to placebo with respect to the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms.

Timeline

Start
2026-03-03
Primary completion
2028-12
Completion
2029-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ziresovir Small molecule 200 mg Oral
Subject Ziresovir Small molecule 300 mg Oral