A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV
RSV Infection
About this trial
This is an interventional treatment trial for RSV Infection focused on measuring XW001, Respiratory Syncytial Virus
Eligibility Criteria
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.
Sites / Locations
- West China Second University Hospital, Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
C1-XW001
C1-Placebo
C2-XW001
C2-Placebo
C3-XW001
C3-Placebo
Low dose of XW001 once daily
Matched Placebo once daily
Medium dose of XW001 once daily
Matched Placebo once daily
High dose of XW001 once daily
Matched Placebo once daily