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

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

Study Overview

• Status: Completed
• Conditions: RSV Infection
• Intervention / Treatment: Drug: XW001; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Second University Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Investigators: Principal Investigator: Hanmin Liu, Dr, West China Second University Hospital; Principal Investigator: Qin Yu, West China Second University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): January 8, 2024

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Respiratory Syncytial Virus; XW001
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: SCW1201-3021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No