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
Joincare Pharmaceutical Group Industry Co., Ltd
177 participants
Nov 7, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria8
- 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.
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Interventions
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.
Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07357051