JKN2301 Dry Suspension for Uncomplicated Influenza in Pediatric Patients
JKN2301 Dry Suspension
+ Oseltamivir Placebo
+ Oseltamivir
Treatment Study
Summary
Study start date: November 7, 2025
Actual date on which the first participant was enrolled.This is a phase III study focused on treating uncomplicated influenza in children aged 2 to 11 years. The main goal is to evaluate the effectiveness of a medication called JKN2301 Dry Suspension. This research is important as it aims to find a potential new treatment for influenza in children, addressing a common health concern in this age group.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.177 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 to 11 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, ChinaOpen First Affiliated Hospital of Guangzhou Medical University in Google Maps