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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Viral Infection
• Intervention / Treatment: Drug: JKN2301 Dry Suspension; Drug: Oseltamivir Placebo; Drug: Oseltamivir; Drug: JKN2301 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 177
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ying Yang; Phone Number: +86-0755-33268688; Email: overseas@joincare.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JKN2301 + Oseltamivir Placebo	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.
Active Comparator: Oseltamivir + JKN2301 Placebo	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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Amides; Acetamides; Oseltamivir
• Other Study ID Numbers: JKN2301-III-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No