Study of AK0529 to Evaluate Safety and Effectiveness in Hospitalized Infants with Respiratory Syncytial Virus Infection Randomized, Double-Blind, Placebo-Controlled Phase III Trial with Oral Treatment

What this Trial Is About

Researchers are investigating the safety and effectiveness of AK0529, an oral medicine that targets the fusion protein on the Respiratory Syncytial Virus (RSV) surface, in infants aged 1 to 24 months hospitalized with RSV infection. RSV is a common and serious respiratory infection in infants, often leading to hospitalization and severe lung problems such as pneumonia. This Phase III, randomized, double-blind, placebo-controlled study focuses on infants with moderate to severe RSV infection to assess how well AK0529 works and how safe it is. The study plans to enroll 180 infants who will be randomly assigned to receive either AK0529 or a placebo. The treatment involves taking the medication by mouth twice daily for five days, with the dose adjusted according to the infant's weight. The study includes a screening period of 36 hours before the first dose, a five-day treatment period, and a nine-day follow-up phase to monitor safety after the last dose. Researchers will collect nasal samples for virus testing before and during treatment and follow-up days. Participants will be regularly assessed using the Wang bronchiolitis clinical score to measure symptom changes, which is the primary outcome assessed on Day 3. Safety will be monitored through tracking adverse events, vital signs, oxygen levels, physical exams, laboratory tests, and heart monitoring via ECG. The total participation time for each infant is up to 17 days, during which detailed observations and tests will ensure careful evaluation of the treatment's impact and safety.

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