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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

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
2-11 years
All
Phase 3

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Overview

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

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.

Study details
    Respiratory Viral Infection

NCT07357051

Joincare Pharmaceutical Group Industry Co., Ltd

1 February 2026

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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