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RECRUITING
NCT07357051
PHASE3

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

177

Start Date

2025-11-07

Completion Date

2026-04-15

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

DRUG

JKN2301 Dry Suspension

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

DRUG

Oseltamivir Placebo

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

DRUG

Oseltamivir

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

DRUG

JKN2301 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