JKN2301 dry suspension versus oseltamivir for treating flu in children 2 to under 12.
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
Run by Joincare Pharmaceutical Group Industry Co., Ltd · NCT07357051 · Data updated 2026-11-12
This study tests whether JKN2301 dry suspension is safe and helps treat uncomplicated influenza in children aged 2 to 11, compared with oseltamivir or placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 11 Years |
| Sex | All |
| Enrollment | 177 (estimated) |
| Sponsor | Joincare Pharmaceutical Group Industry Co., Ltd Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | November 7, 2025 |
| Main results expected | January 31, 2026 |
| Study ends | April 15, 2026 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07357051 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 2 to under 12 with early, uncomplicated influenza confirmed by rapid test or PCR who can take an oral suspension and whose parent/guardian can give consent are ideal candidates.
✕Probably not a fit
Children with severe or complicated influenza requiring hospitalization, significant immunosuppression, concurrent bacterial infections needing systemic therapy, known hypersensitivity to study drugs, or recent antiviral use are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase III pediatric trial enrolls children aged 2 to under 12 who present early with confirmed uncomplicated influenza. Participants will receive JKN2301 dry suspension, oseltamivir, or matching placebos and will be followed for safety, pharmacokinetics, and signs of clinical benefit. Diagnosis is confirmed by local rapid test or central PCR and dosing is oral suspension for those able to swallow it. The study excludes children with severe or complicated illness, significant immunosuppression, or recent use of other antivirals.
Why it matters
Potential benefit: If successful, JKN2301 could offer a new oral antiviral option for young children with uncomplicated influenza that may shorten symptoms and illness duration.
How similar studies have gone: Existing antivirals such as oseltamivir have shown benefit in pediatric influenza, while JKN2301 is a newer investigational formulation being tested against those standards.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Ying Yang
- Email: overseas@joincare.com
- Phone: +86-0755-33268688
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.