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

Launched by HANGZHOU SCIWIND BIOSCIENCES CO., LTD. · Mar 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new inhalation treatment called XW001 for young children who have been diagnosed with respiratory syncytial virus (RSV), a common virus that can cause breathing problems. The trial aims to see how safe this treatment is and how well it works in children aged 1 to 24 months who are showing symptoms of RSV. To participate, children need to weigh between 3 to 20 kilograms and have tested positive for RSV within the last 36 hours. It's important that parents or guardians can understand the study and give their consent for their child to join.

Participants in this study will receive either the XW001 treatment or a placebo (a treatment that looks like the real one but has no active ingredients) without knowing which one they are getting. This helps researchers compare the effects of the treatment against no treatment. The study is currently looking for participants, and children with certain health conditions, like a weakened immune system or recent surgeries, may not be eligible. Families can expect close monitoring and care throughout the trial to ensure their child's safety.

Gender

ALL

Eligibility 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.