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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
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
Conditions
Interventions
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.
Locations (1)
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China