Clinical trial NCT05779995: A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: RSV Infection
Keywords: XW001
Respiratory Syncytial Virus
Lead sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

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.

Primary outcomes:
measure: Incidence of Adverse Events after receiving XW001
timeFrame: Day 1 to Day 28
Secondary outcomes:
measure: Change from baseline in RSV load via nasopharyngeal swab
timeFrame: Baseline, Day 2 to Day 8
measure: Change from baseline in Wang Respiratory Score
timeFrame: Baseline, Day 2 to Day 8
measure: Pharmacokinetics-Plasma level of XW001
timeFrame: Baseline, Day 8
measure: Immunogenicity-Anti-drug Antibody of XW001
timeFrame: Baseline, Day 28
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Second University Hospital
name: Hanmin Liu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Second University Hospital
name: Qin Yu
role: PRINCIPAL_INVESTIGATOR
References: