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
Sponsored by Joincare Pharmaceutical Group Industry Co., Ltd
About this trial
Last updated 4 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended a month ago
What is this trial about?
What are the participation requirements?
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.