Trials / Completed
CompletedNCT05779995
A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Hangzhou Sciwind Biosciences Co., Ltd. · Industry
- Sex
- All
- Age
- 1 Month – 24 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XW001 | Inhalation solution |
| DRUG | Placebo | Inhalation solution with matched volume |
Timeline
- Start date
- 2023-04-20
- Primary completion
- 2023-10-10
- Completion
- 2024-01-08
- First posted
- 2023-03-22
- Last updated
- 2025-08-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05779995. Inclusion in this directory is not an endorsement.