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

RSV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779995
• Other study ID #: SCW1201-3021
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 20, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: Hangzhou Sciwind Biosciences Co., Ltd.
• Contact: Lei Guan
• Phone: +86-18910900897
• Email: lei.guan[@]sciwindbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

Drug:
• XW001
Inhalation solution
• Placebo
Inhalation solution with matched volume

Locations

Country	Name	City	State
China	West China Second University Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Sciwind Biosciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events after receiving XW001		Day 1 to Day 28
Secondary	Change from baseline in RSV load via nasopharyngeal swab		Baseline, Day 2 to Day 8
Secondary	Change from baseline in Wang Respiratory Score		Baseline, Day 2 to Day 8
Secondary	Pharmacokinetics-Plasma level of XW001		Baseline, Day 8
Secondary	Immunogenicity-Anti-drug Antibody of XW001		Baseline, Day 28