The goal of this phase III study is to learn if JKN2301 Dry Suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
177
Single oral dose, administered according to a weight-tiered dosing scheme.
Oral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir.
Oral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen.
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGIncidence, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline through Day 15
Clinically significant changes in laboratory parameters, vital signs, physical examination, and ECG
Time frame: Baseline through Day 15
Plasma concentration-time profiles of JKN2301 and its relevant metabolites
Time frame: At multiple timepoints up to Day 6
Time to alleviation of all influenza symptoms
Time frame: From treatment initiation up to Day 15
Duration of fever
Time frame: From treatment initiation up to Day 15
Time to cessation of viral shedding assessed by viral culture
Time frame: From treatment initiation up to Day 9
Change from baseline in viral titer
Time frame: Baseline to Day 9
Incidence of influenza-related complications
Time frame: Up to Day 15
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Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301.