Recruiting

JKN2301 Dry Suspension for Uncomplicated Influenza in Pediatric Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

JKN2301 Dry Suspension

+ Oseltamivir Placebo

+ Oseltamivir

Drug
Who is being recruted

From 2 to 11 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorJoincare Pharmaceutical Group Industry Co., Ltd
Study ContactYing Yang
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA 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
Principal SponsorJoincare Pharmaceutical Group Industry Co., Ltd
Study ContactYing Yang
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

177 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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.
Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study 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

Recruiting

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, ChinaOpen First Affiliated Hospital of Guangzhou Medical University in Google Maps
Recruiting
One Study Center