NCT07357051

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Viral Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-07
• Primary completion: 2026-01-31
• Completion: 2026-04-15
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: China