A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants

Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of hospitalization for severe respiratory infections in infants. Serious respiratory problems such as pneumonia caused by RSV are one of the leading causes of death from respiratory diseases in infants. AK0529 targets the Pre-F (fusion) protein on the surface of the viral envelope. Specifically, it prevents the virus from invading uninfected cells and inhibits the fusion between host cells by inhibiting the fusion of the F (fusion) proteins on the surface of the RSV envelope, thus providing the effects of anti-RSV infection. This is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of AK0529 in hospitalized infants aged 1 to 24 months with RSV infection. Considering the benefits of AK0529 in the population with RSV infection, hospitalized infants with moderate to severe RSV infection were selected as the target population for this study.

NCT Number	NCT06775405
Lead Sponsor	Shanghai Ark Biopharmaceutical Co., Ltd.
Conditions	Respiratory Synctial Virus Infections
Enrollment	180 participants
Start Date	2024-02-29
Primary Completion	2025-08 (estimated)
Study Completion	2025-09 (estimated)
Updated on ClinicalTrials.gov	2025-01-15