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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Double-blind, Placebo-controlled Phase Ib/Ⅱa Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of XW001 Inhalation in Children With Respiratory Syncytial Virus (RSV) Infection in China

Conditions
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RSV Infection

Intervention / Treatment
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* Drug: XW001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C1-XW001<br>Low dose of XW001 once daily | Drug: XW001<br>* Inhalation solution<br>|
| Placebo Comparator: C1-Placebo<br>Matched Placebo once daily | Drug: Placebo<br>* Inhalation solution with matched volume<br>|
| Experimental: C2-XW001<br>Medium dose of XW001 once daily | Drug: XW001<br>* Inhalation solution<br>|
| Placebo Comparator: C2-Placebo<br>Matched Placebo once daily | Drug: Placebo<br>* Inhalation solution with matched volume<br>|
| Experimental: C3-XW001<br>High dose of XW001 once daily | Drug: XW001<br>* Inhalation solution<br>|
| Placebo Comparator: C3-Placebo<br>Matched Placebo once daily | Drug: Placebo<br>* Inhalation solution with matched volume<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events after receiving XW001 |  | Day 1 to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XW001, Respiratory Syncytial Virus