Clinical Trials/NCT05779995

NCT05779995

Completed

Phase 1

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

Hangzhou Sciwind Biosciences Co., Ltd.1 site in 1 country61 target enrollmentApril 20, 2023

ConditionsRSV Infection

InterventionsPlacebo XW001

DrugsXW001 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: RSV Infection
Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
Enrollment: 61
Locations: 1
Primary Endpoint: Incidence of Adverse Events after receiving XW001
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 20, 2023

End Date

January 8, 2024

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hangzhou Sciwind Biosciences Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Arms & Interventions

C1-Placebo

Matched Placebo once daily

Intervention: Placebo

C1-XW001

Low dose of XW001 once daily

Intervention: XW001

C2-XW001

Medium dose of XW001 once daily

Intervention: XW001

C2-Placebo

Matched Placebo once daily

Intervention: Placebo

C3-XW001

High dose of XW001 once daily

Intervention: XW001

C3-Placebo

Matched Placebo once daily

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of Adverse Events after receiving XW001

Time Frame: Day 1 to Day 28

Secondary Outcomes

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)