Respiratory Viral InfectionPhase 3NCT07357051
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 Phase 3 study testing JKN2301 Dry Suspension and Oseltamivir in people with Respiratory Viral Infection, run by Joincare Pharmaceutical Group Industry Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Respiratory Viral Infection
- What is being tested?
- JKN2301 Dry Suspension and Oseltamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2025to 15 Apr 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
About this study
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
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
- Being tested
- JKN2301 Dry Suspension, Oseltamivir Placebo, Oseltamivir, JKN2301 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JKN2301 Dry SuspensionDrug
Single oral dose, administered according to a weight-tiered dosing scheme.
Oseltamivir PlaceboDrug
Oral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir.
OseltamivirDrug
Oral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen.
JKN2301 PlaceboDrug
Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301.
| Study group | Role | What they receive |
|---|---|---|
| JKN2301 + Oseltamivir Placebo | Experimental | Not described Receives: Drug: JKN2301 Dry Suspension; Drug: Oseltamivir Placebo |
| Oseltamivir + JKN2301 Placebo | Active comparator | Not described Receives: Drug: Oseltamivir; Drug: JKN2301 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline through Day 15
Clinically significant changes in laboratory parameters, vital signs, physical examination, and ECG
Measured: Baseline through Day 15
Secondary outcomes (6)
Plasma concentration-time profiles of JKN2301 and its relevant metabolites
Measured: At multiple timepoints up to Day 6
Time to alleviation of all influenza symptoms
Measured: From treatment initiation up to Day 15
Duration of fever
Measured: From treatment initiation up to Day 15
Time to cessation of viral shedding assessed by viral culture
Measured: From treatment initiation up to Day 9
Change from baseline in viral titer
Measured: Baseline to Day 9
Incidence of influenza-related complications
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start7 Nov 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Viral InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357051
- Sponsor's protocol ID
- JKN2301-III-01
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07357051
- Acronym / sponsor ID
- JKN2301-III-01
- Conditions
- Respiratory Viral Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JKN2301 + Oseltamivir Placebo | Experimental | Drug: JKN2301 Dry Suspension, Drug: Oseltamivir Placebo |
| Oseltamivir + JKN2301 Placebo | Active comparator | Drug: Oseltamivir, Drug: JKN2301 Placebo |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JKN2301 Dry SuspensionSingle oral dose, administered according to a weight-tiered dosing scheme. | Drug | JKN2301 + Oseltamivir Placebo |
| Oseltamivir PlaceboOral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir. | Drug | JKN2301 + Oseltamivir Placebo |
| OseltamivirOral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen. | Drug | Oseltamivir + JKN2301 Placebo |
| JKN2301 PlaceboSingle oral dose, matched to the weight-tiered dosing scheme of active JKN2301. | Drug | Oseltamivir + JKN2301 Placebo |
Primary outcome
Incidence, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline through Day 15
Clinically significant changes in laboratory parameters, vital signs, physical examination, and ECG
Time frame: Baseline through Day 15
6 secondary outcomes
Plasma concentration-time profiles of JKN2301 and its relevant metabolites
Time frame: At multiple timepoints up to Day 6
Time to alleviation of all influenza symptoms
Time frame: From treatment initiation up to Day 15
Duration of fever
Time frame: From treatment initiation up to Day 15
Time to cessation of viral shedding assessed by viral culture
Time frame: From treatment initiation up to Day 9
Change from baseline in viral titer
Time frame: Baseline to Day 9
Incidence of influenza-related complications
Time frame: Up to Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JKN2301 Dry Suspension and Oseltamivir in people with Respiratory Viral Infection, run by Joincare Pharmaceutical Group Industry Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Yang (+86-0755-33268688, overseas@joincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs) (time frame: Baseline through Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.