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

Sciwind Biosciences

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: RSV Infection

Treatments: Drug: XW001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05779995

SCW1201-3021

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 6 patient groups, including a placebo group

C1-XW001

Experimental group

Description:

Low dose of XW001 once daily

Treatment:

Drug: XW001

C1-Placebo

Placebo Comparator group

Description:

Matched Placebo once daily

Treatment:

Drug: Placebo

C2-XW001

Experimental group

Description:

Medium dose of XW001 once daily

Treatment:

Drug: XW001

C2-Placebo

Placebo Comparator group

Description:

Matched Placebo once daily

Treatment:

Drug: Placebo

C3-XW001

Experimental group

Description:

High dose of XW001 once daily

Treatment:

Drug: XW001

C3-Placebo

Placebo Comparator group

Description:

Matched Placebo once daily

Treatment:

Drug: Placebo