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

NCT07357051 | Recruiting Phase 3

• 1 other identifier: JKN2301-III-01
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Viral Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (2)

JKN2301 + Oseltamivir Placebo

EXPERIMENTAL

Drug: JKN2301 Dry Suspension; Drug: Oseltamivir Placebo

Oseltamivir + JKN2301 Placebo

ACTIVE COMPARATOR

Drug: Oseltamivir; Drug: JKN2301 Placebo

Interventions

JKN2301 Dry Suspension DRUG

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

JKN2301 + Oseltamivir Placebo

Oseltamivir Placebo DRUG

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

JKN2301 + Oseltamivir Placebo

Oseltamivir DRUG

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

Oseltamivir + JKN2301 Placebo

JKN2301 Placebo DRUG

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

Oseltamivir + JKN2301 Placebo

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joincare Pharmaceutical Group Industry Co., Ltd: lead

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

Oseltamivir

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Ying Yang

CONTACT

+86-0755-33268688; overseas@joincare.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 21, 2026
• Study Start: November 7, 2025
• Primary Completion: January 31, 2026
• Study Completion: April 15, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)