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Clinical Trials in China / NCT07357051
Recruiting Phase 3

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

NCT07357051 · tracked via the Priya Life Science China tracker
Sponsor
Joincare Pharmaceutical Group Industry Co., Ltd
Phase
Phase 3
Started
2025-11-07
Last updated
2026-01-21

Condition(s) studied

Respiratory Viral Infection

Investigational drug(s) / intervention(s)

JKN2301 Dry SuspensionOseltamivir PlaceboOseltamivirJKN2301 Placebo

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.

Study 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

Sex
ALL
Min age
2 Years
Max age
11 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting

On this site

📄 Tamiflu (oseltamivir) drug profile →

More Joincare Pharmaceutical Group Industry Co., Ltd trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07357051 on ClinicalTrials.gov ↗ ← All trials in China