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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-11
SponsorJoincare Pharmaceutical Group Industry Co., Ltd

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

177 Participants
are divided into 2 treatment groups