RecruitingPhase 3NCT07357051

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


Sponsor

Joincare Pharmaceutical Group Industry Co., Ltd

Enrollment

177 participants

Start Date

Nov 7, 2025

Study Type

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

Min Age: 2 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called JKN2301 Dry Suspension, a drug called JKN2301 Placebo, and others for people with respiratory viral infection. The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJKN2301 Dry Suspension

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

DRUGOseltamivir Placebo

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

DRUGOseltamivir

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

DRUGJKN2301 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

View Full Details on ClinicalTrials.gov

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NCT07357051


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