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

Joincare Pharmaceutical Group Industry Co., Ltd

Status and phase

Enrolling

Phase 3

Conditions

Respiratory Viral Infection

Treatments

Drug: Oseltamivir Placebo

Drug: Oseltamivir

Drug: JKN2301 Dry Suspension

Drug: JKN2301 Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07357051

JKN2301-III-01

Details and patient eligibility

About

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.

Enrollment

177 estimated patients

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

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.