A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV

In this study, eligible participants will be randomized in a 4:1 ratio to receive XW001 inhalation (one of three dosage groups) or placebo once a day for 7 days.

Inclusion criteria

• Male or female, 1 to 24 months (inclusive) at screening;
• Weight: 3-20 kg, inclusive;
• Positive RSV test within 36 hours before randomization;
• Symptomatic at screening and randomization, and the onset of RSV symptoms is within 5 days prior to the first dose of XW001;
• Parents/legal guardians are able to understand the purpose and procedures of the study, and are able to provide informed consent.

Exclusion criteria

• Immunocompromised as determined by the investigator;
• Known to have undergone or planned for bone marrow, stem cells, or other organ transplants, or are currently on immunosuppressive treatment;
• Positive for HBV, HCV or HIV, or patient <6 months old whose mother is positive for HIV;
• History of seizures or epilepsy, including febrile seizure;
• Known to have received any prohibited medications defined by the protocol within 3 days prior to randomization;
• History of any surgery within 30 days prior to randomization;
• Severe dental or facial deformity that will impact on usage of nebulizer;
• History of receiving measles, mumps, rubella or other vaccines within 7 days prior to screening;
• Known to have received any investigational medicinal products or devices in the past 30 days;
• Any other underlying conditions that make the patient unlikely to complete the study in the opinion of the investigator.