Respiratory Viral Infection
Conditions
Brief summary
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
DRUGJKN2301 Dry Suspension
Single oral dose, administered according to a weight-tiered dosing scheme.
Oral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir.
DRUGOseltamivir
Oral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen.
DRUGJKN2301 Placebo
Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301.
Sponsors
Joincare Pharmaceutical Group Industry Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs) | Baseline through Day 15 |
| Clinically significant changes in laboratory parameters, vital signs, physical examination, and ECG | Baseline through Day 15 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration-time profiles of JKN2301 and its relevant metabolites | At multiple timepoints up to Day 6 |
| Time to alleviation of all influenza symptoms | From treatment initiation up to Day 15 |
| Duration of fever | From treatment initiation up to Day 15 |
| Time to cessation of viral shedding assessed by viral culture | From treatment initiation up to Day 9 |
| Change from baseline in viral titer | Baseline to Day 9 |
| Incidence of influenza-related complications | Up to Day 15 |
Countries
China
Contacts
CONTACTYing Yang
Outcome results
None listed