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
JKN2301 Dry Suspension: Single oral dose, administered according to a weight-tiered dosing scheme.
Oseltamivir Placebo: Oral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir.
Oseltamivir: Oral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen.
JKN2301 Placebo: Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301.
Study 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
Sex
ALL
Min age
2 Years
Max age
11 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs) — Baseline through Day 15
Clinically significant changes in laboratory parameters, vital signs, physical examination, and ECG — Baseline through Day 15
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Guangzhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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