NCT07357051 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
| NCT ID | NCT07357051 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Joincare Pharmaceutical Group Industry Co., Ltd |
| Condition | Respiratory Viral Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 177 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 177 participants in total. It began in 2025-11-07 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07357051 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 11 Years, studying Respiratory Viral Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07357051 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 177 participants.
Is NCT07357051 currently recruiting?
Yes, NCT07357051 is actively recruiting participants. Contact the research team at overseas@joincare.com for enrollment information.
Where is the NCT07357051 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07357051 clinical trial?
NCT07357051 is sponsored by Joincare Pharmaceutical Group Industry Co., Ltd. The trial plans to enroll 177 participants.