JKN2301 dry suspension versus oseltamivir for treating flu in children 2 to under 12.
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
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 |
| Enrollment | 177 (estimated) |
| Ages | 2 Years to 11 Years |
| Sex | All |
| Sponsor | Joincare Pharmaceutical Group Industry Co., Ltd Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07357051 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Existing antivirals such as oseltamivir have shown benefit in pediatric influenza, while JKN2301 is a newer investigational formulation being tested against those standards.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.