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

NCT05779995 | Completed Phase 1

• 1 other identifier: SCW1201-3021
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Conditions

RSV Infection

Keywords

XW001; Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events after receiving XW001

  Day 1 to Day 28

Secondary Outcomes (4)

• 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

Study Arms (6)

C1-XW001

EXPERIMENTAL

Low dose of XW001 once daily

Drug: XW001

C1-Placebo

PLACEBO COMPARATOR

Matched Placebo once daily

Drug: Placebo

C2-XW001

EXPERIMENTAL

Medium dose of XW001 once daily

Drug: XW001

C2-Placebo

PLACEBO COMPARATOR

Matched Placebo once daily

Drug: Placebo

C3-XW001

EXPERIMENTAL

High dose of XW001 once daily

Drug: XW001

C3-Placebo

PLACEBO COMPARATOR

Matched Placebo once daily

Drug: Placebo

Interventions

XW001 DRUG

Inhalation solution

C1-XW001; C2-XW001; C3-XW001

Placebo DRUG

Inhalation solution with matched volume

C1-Placebo; C2-Placebo; C3-Placebo

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Sciwind Biosciences Co., Ltd.: lead

Study Sites (1)

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

XW001

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Hanmin Liu, Dr

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

• Qin Yu

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 22, 2023
• Study Start: April 20, 2023
• Primary Completion: October 10, 2023
• Study Completion: January 8, 2024
• Last Updated: August 17, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)