RSV Infection
Conditions
Keywords
XW001, Respiratory Syncytial Virus
Brief summary
This is a randomized, double-blind, placebo-controlled Phase Ib/IIa study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of XW001 inhalation in children with RSV infection in China
Detailed description
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.
Interventions
DRUGXW001
Inhalation solution
DRUGPlacebo
Inhalation solution with matched volume
Sponsors
Hangzhou Sciwind Biosciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
1. Male or female, 1 to 24 months (inclusive) at screening; 2. Weight: 3-20 kg, inclusive; 3. Positive RSV test within 36 hours before randomization; 4. Symptomatic at screening and randomization, and the onset of RSV symptoms is within 5 days prior to the first dose of XW001; 5. Parents/legal guardians are able to understand the purpose and procedures of the study, and are able to provide informed consent.
Exclusion criteria
1. Immunocompromised as determined by the investigator; 2. Known to have undergone or planned for bone marrow, stem cells, or other organ transplants, or are currently on immunosuppressive treatment; 3. Positive for HBV, HCV or HIV, or patient \<6 months old whose mother is positive for HIV; 4. History of seizures or epilepsy, including febrile seizure; 5. Known to have received any prohibited medications defined by the protocol within 3 days prior to randomization; 6. History of any surgery within 30 days prior to randomization; 7. Severe dental or facial deformity that will impact on usage of nebulizer; 8. History of receiving measles, mumps, rubella or other vaccines within 7 days prior to screening; 9. Known to have received any investigational medicinal products or devices in the past 30 days; 10. Any other underlying conditions that make the patient unlikely to complete the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events after receiving XW001 | Day 1 to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in RSV load via nasopharyngeal swab | Baseline, Day 2 to Day 8 |
| Change from baseline in Wang Respiratory Score | Baseline, Day 2 to Day 8 |
| Pharmacokinetics-Plasma level of XW001 | Baseline, Day 8 |
| Immunogenicity-Anti-drug Antibody of XW001 | Baseline, Day 28 |
Countries
China
Outcome results
None listed