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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Respiratory Viral Infection

In brief

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.

Key facts

Study ID: NCT07357051
Run by: Joincare Pharmaceutical Group Industry Co., Ltd
People needed: 177
Starts: 2025-11-07
Expected to finish: 2026-04-15
Last updated by the study team: 2026-01-21

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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