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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

ConditionRespiratory Viral Infection
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • JKN2301 Dry Suspension

    Drug

    Single oral dose, administered according to a weight-tiered dosing scheme.

  • Oseltamivir Placebo

    Drug

    Oral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir.

  • Oseltamivir

    Drug

    Oral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen.

  • JKN2301 Placebo

    Drug

    Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301.

Treatment groups

177 Participants
are divided into 2 treatment groups
Group A: JKN2301 + Oseltamivir PlaceboExperimental treatment 2 interventions
Group B: Oseltamivir + JKN2301 PlaceboActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Incidence, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)

Time frame
Baseline through Day 15
2

Clinically significant changes in laboratory parameters, vital signs, physical examination, and ECG

Time frame
Baseline through Day 15

Secondary outcomes

1

Plasma concentration-time profiles of JKN2301 and its relevant metabolites

Time frame
At multiple timepoints up to Day 6
2

Time to alleviation of all influenza symptoms

Time frame
From treatment initiation up to Day 15
3

Duration of fever

Time frame
From treatment initiation up to Day 15
4

Time to cessation of viral shedding assessed by viral culture

Time frame
From treatment initiation up to Day 9

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joincare Pharmaceutical Group Industry Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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