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

Phase 1

Recruiting

• Conditions: RSV Infection
• Interventions: Drug: XW001; Drug: Placebo

• Registration Number: NCT05779995
• Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-22
• Study Start: 2023-04-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C1-XW001	XW001	Low dose of XW001 once daily
C1-Placebo	Placebo	Matched Placebo once daily
C2-XW001	XW001	Medium dose of XW001 once daily
C2-Placebo	Placebo	Matched Placebo once daily
C3-Placebo	Placebo	Matched Placebo once daily
C3-XW001	XW001	High dose of XW001 once daily

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events after receiving XW001	Day 1 to Day 28

Secondary Outcome Measures

Name	Time	Method
Change from baseline in RSV load via nasopharyngeal swab	Baseline, Day 2 to Day 8
Immunogenicity-Anti-drug Antibody of XW001	Baseline, Day 28
Change from baseline in Wang Respiratory Score	Baseline, Day 2 to Day 8
Pharmacokinetics-Plasma level of XW001	Baseline, Day 8

Trial Locations

Locations (1)

West China Second University Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China