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RECRUITINGPhase 3INTERVENTIONAL

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

A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form/assent. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

JKN2301 Dry Suspension

Single oral dose, administered according to a weight-tiered dosing scheme.

DRUG

Oseltamivir Placebo

Oral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir.

DRUG

Oseltamivir

Oral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen.

DRUG

JKN2301 Placebo

Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301.

Locations (1)

First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China