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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Incidence of Adverse Events after receiving XW001
Time frame: Day 1 to Day 28
Change from baseline in RSV load via nasopharyngeal swab
Time frame: Baseline, Day 2 to Day 8
Change from baseline in Wang Respiratory Score
Time frame: Baseline, Day 2 to Day 8
Pharmacokinetics-Plasma level of XW001
Time frame: Baseline, Day 8
Immunogenicity-Anti-drug Antibody of XW001
Time frame: Baseline, Day 28
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