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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

RecruitingPhase 3Ages 2 Years - 11 YearsAllJoincare Pharmaceutical Group Industry Co., Ltd
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • JKN2301 Dry Suspension
  • Oseltamivir Placebo
  • Oseltamivir
  • JKN2301 Placebo
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Where

1 site
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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