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

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) is a Phase 3 interventional studying Respiratory Viral Infection, sponsored by Joincare Pharmaceutical Group Industry Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Respiratory Viral Infection, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 177 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Respiratory Viral Infection subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form/assent. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07357051), the sponsor (Joincare Pharmaceutical Group Industry Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07357051 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07357051?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07357051?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07357051. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07357051. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.