A Study of AK0529 in Chinese Infants Hospitalized With RSV

A Randomized, Double-blind, Placebo-controlled, 2-part Study of Orally Administered AK0529 to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Multiple Doses in Hospitalized Infants With Respiratory Syncytial Virus Infection

This is a randomized, double-blind, placebo-controlled, multicenter, phase III study to be conducted in infants hospitalized with RSV infection in China. The main objectives of this study are to investigate the efficacy and safety of AK0529 in Chinese infants.

Main Inclusion Criteria:

• Male or female patients of any ethnicity with an age-adjusted for any prematurity of ≥1 month and ≤24 months.
• Diagnosis of RSV infection by any virological means within 36 hours preceding the initial dose.
• The time from the onset caused by RSV infection to the first dose should be ≤ 7 days. Time of onset is defined as the time the first respiratory or systemic signs or symptoms of RSV infection confirmed by the investigator.
• Body weight ≥ 2.5 kg and ≤ 20 kg at screening.
• For patients aged <12 months, an occipitofrontal head circumference should be within the normal range for age and gender.
• Bronchiolitis score ≥ 5.
• The parent/legal guardian must have provided written informed consent for the patient to participate.

Main Exclusion Criteria:

• Patients who have used any prohibited medications within 72 hours prior to expected administration and those who have used inhaled or systemic glucocorticosteroids within 24 hours prior to administration.
• Patients (or mothers of patients younger than 6 months of age) with a known HIV-positive history or patients highly suspected HIV-positive by the investigator.
• Patients with known co-infection with influenza virus.
• Patient known to have pneumonia caused by bacterial infection.
• Patients requiring vasopressors or vasoactive drugs at the time of enrollment.
• Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product.
• Bronchopulmonary dysplasia requiring assisted ventilation at the time of enrolment, except for the result of RSV infection.
• Patients at risk for hypercapnia based on their medical history, except for the result of RSV infection.
• Patient with airway malformations and congenital heart diseases, except for isolated patent ductus arteriosus and/or patent foramen ovale.
• Renal failure including renal abnormalities likely to be associated with renal insufficiency.
• Clinical evidence of hepatic decompensation.
• Symptomatic because of congenital metabolic abnormality.
• Chronic or persistent feeding difficulties.
• Known or suspected to have primary immunodeficiency disease.
• Any active or uncontrolled respiratory, cardiac, hepatic, central nervous system or renal disease unrelated to RSV infection at baseline, or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrolment; in case of any question, discuss such cases with the sponsor's medical monitor.
• A history of epilepsy or seizures including febrile seizures.
• History of family history of high allergies or allergies to multiple substances, or presence of severe rash that in the opinion or the investigator renders the patient unsuitable for enrollment.
• The patient's parent or guardian is an employee of the investigator or the study site with direct involvement in the proposed study or other studies under the direction of that investigator of the study site, or any family members of the employees or the investigator.
• Participation in an investigational drug or device study within 30 days prior to the date of screening.
• Failure to satisfy the investigator of fitness to participate for any other reason.