Phase III Study Evaluating AK0529 for Treating RSV Infection in Hospitalized Infants Aged 1 to 24 Months

What this Trial Is About

Respiratory syncytial virus RSV is a common and serious respiratory infection that affects infants worldwide, often leading to hospitalization and severe complications like pneumonia. This trial aims to evaluate the safety and effectiveness of AK0529, a drug targeting the RSV fusion protein to prevent virus spread, in hospitalized infants aged 1 to 24 months with moderate to severe RSV infection. The study is a randomized, double-blind, placebo-controlled phase III trial conducted across multiple centers in China. Participants will be randomly assigned to receive either AK0529 or a placebo. The medication is given orally twice daily for five days, with doses adjusted based on the infants weight. The study includes a screening period of 36 hours before treatment, followed by the 5-day treatment phase and a 9-day safety follow-up. Dosing will be monitored closely, and samples will be collected to assess viral levels and drug impact. Throughout the study, infants will be regularly evaluated using the Wang bronchiolitis clinical score to monitor respiratory symptoms. Nasopharyngeal samples will be taken for virological testing at multiple points during and after treatment. Safety assessments will include monitoring for adverse events, vital signs, blood oxygen levels, physical exams, laboratory tests, and heart monitoring via ECG. Total participation is expected to last up to 17 days.

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