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

• Status: Recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

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 72 hours 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.