A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.
A Randomized, Double-blind, Two-stage, Placebo-controlled Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of Ziresovir (AK0529) in Adult Patients at High Risk for Respiratory Syncytial Virus (RSV) Infection.
Shanghai Ark Biopharmaceutical Co., Ltd.
290 participants
Mar 3, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Active Substance: AK0529 Pharmaceutical Form: Enteric Capsules Route of Administration: Oral
Active Substance: Placebo Pharmaceutical Form: Enteric Capsules Route of Administration: Oral
Locations(9)
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NCT07658534