Evaluating XW001 inhalation for treating RSV in children
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
This study is testing a new inhaled treatment called XW001 to see if it helps young children with RSV infection feel better and stay safe while using it.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Month to 24 Months |
| Sex | All |
| Sponsor | Hangzhou Sciwind Biosciences Co., Ltd. Industry-sponsored |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT05779995 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase Ib/IIa study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of XW001 inhalation in children diagnosed with RSV infection. Participants aged 1 to 24 months will be randomly assigned in a 4:1 ratio to receive either XW001 or a placebo once daily for 7 days. The study aims to gather comprehensive data on the treatment's effects and safety profile in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 24 months who have tested positive for RSV and are symptomatic.
Not a fit: Patients who are immunocompromised or have a history of certain medical conditions, such as seizures or recent surgeries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for young children suffering from RSV infection.
How similar studies have performed: While this approach is novel, similar studies targeting RSV have shown promise in developing effective treatments.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Chengdu, Sichuan
- West China Second University Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Hanmin Liu, Dr — West China Second University Hospital
- Study coordinator: Lei Guan
- Email: lei.guan@sciwindbio.com
- Phone: +86-18910900897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.