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

NCT ID: NCT05779995

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2024-01-08

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.

Conditions

RSV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

C1-XW001

Low dose of XW001 once daily

Group Type: EXPERIMENTAL

XW001

Intervention Type: DRUG

Inhalation solution

C1-Placebo

Matched Placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inhalation solution with matched volume

C2-XW001

Medium dose of XW001 once daily

Group Type: EXPERIMENTAL

XW001

Intervention Type: DRUG

Inhalation solution

C2-Placebo

Matched Placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inhalation solution with matched volume

C3-XW001

High dose of XW001 once daily

Group Type: EXPERIMENTAL

XW001

Intervention Type: DRUG

Inhalation solution

C3-Placebo

Matched Placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inhalation solution with matched volume

Interventions

XW001

Inhalation solution

Intervention Type: DRUG

Placebo

Inhalation solution with matched volume

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Sciwind Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanmin Liu, Dr

Role: PRINCIPAL_INVESTIGATOR

West China Second University Hospital

Qin Yu

Role: PRINCIPAL_INVESTIGATOR

West China Second University Hospital

Locations

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

SCW1201-3021

Identifier Type: -

Identifier Source: org_study_id