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Recruiting NCT07357051

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 Interventional Respiratory Viral Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JKN2301 Dry Suspension, Oseltamivir Placebo, Oseltamivir, JKN2301 Placebo.
Who it may be relevant to
Registry conditions: Respiratory Viral Infection. Basic parameters: 2 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled 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

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.

Interventions

  • Drug JKN2301 Dry Suspension
    Single oral dose, administered according to a weight-tiered dosing scheme.
  • Drug Oseltamivir Placebo
    Oral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir.
  • Drug Oseltamivir
    Oral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen.
  • Drug JKN2301 Placebo
    Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301.

Primary outcome measures

  • Incidence, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs) [Time frame: Baseline through Day 15]
  • Clinically significant changes in laboratory parameters, vital signs, physical examination, and ECG [Time frame: Baseline through Day 15]
Secondary outcome measures (6)
  • Plasma concentration-time profiles of JKN2301 and its relevant metabolites [Time frame: At multiple timepoints up to Day 6]
  • Time to alleviation of all influenza symptoms [Time frame: From treatment initiation up to Day 15]
  • Duration of fever [Time frame: From treatment initiation up to Day 15]
  • Time to cessation of viral shedding assessed by viral culture [Time frame: From treatment initiation up to Day 9]
  • Change from baseline in viral titer [Time frame: Baseline to Day 9]
  • Incidence of influenza-related complications [Time frame: Up to Day 15]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • First Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT07357051 · JKN2301-III-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗