Phase III Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of JKN2301 Dry Suspension in Pediatric Patients Aged 2 to Under 12 Years With Influenza

Inclusion criteria

• Pediatric patients within the specified age range.
• Clinical presentation consistent with influenza, confirmed by a positive local rapid test or central laboratory PCR test.
• Presentation for treatment within the early symptomatic phase of influenza illness.
• Presence of fever and at least one respiratory symptom.
• Ability to swallow oral suspension.
• Parent/guardian and patient (as age-appropriate) able to provide informed consent/assent.

Exclusion criteria

• Clinical signs suggestive of severe or complicated influenza infection
• requiring inpatient management.
• Presence of a concurrent bacterial infection requiring systemic therapy.
• Significant immunocompromised, or severe/uncontrolled comorbid conditions.
• History of hypersensitivity to any component of the investigational products.
• Use of prohibited medications (including other anti-influenza antivirals) within a specified period prior to enrollment.
• Recent participation in another interventional clinical trial.
• Any condition that, in the opinion of the investigator, would jeopardize patient safety or compliance with the study protocol.