Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:30 AM
Study NCT ID:
NCT07357051
Status:
RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053139', 'term': 'Oseltamivir'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 177}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2026-01-08', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'Baseline through Day 15'}, {'measure': 'Clinically significant changes in laboratory parameters, vital signs, physical examination, and ECG', 'timeFrame': 'Baseline through Day 15'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration-time profiles of JKN2301 and its relevant metabolites', 'timeFrame': 'At multiple timepoints up to Day 6'}, {'measure': 'Time to alleviation of all influenza symptoms', 'timeFrame': 'From treatment initiation up to Day 15'}, {'measure': 'Duration of fever', 'timeFrame': 'From treatment initiation up to Day 15'}, {'measure': 'Time to cessation of viral shedding assessed by viral culture', 'timeFrame': 'From treatment initiation up to Day 9'}, {'measure': 'Change from baseline in viral titer', 'timeFrame': 'Baseline to Day 9'}, {'measure': 'Incidence of influenza-related complications', 'timeFrame': 'Up to Day 15'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Viral Infection']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients within the specified age range.\n* Clinical presentation consistent with influenza, confirmed by a positive local rapid test or central laboratory PCR test.\n* Presentation for treatment within the early symptomatic phase of influenza illness.\n* Presence of fever and at least one respiratory symptom.\n* Ability to swallow oral suspension.\n* Parent/guardian and patient (as age-appropriate) able to provide informed consent/assent.\n\nExclusion Criteria:\n\n* Clinical signs suggestive of severe or complicated influenza infection\n* requiring inpatient management.\n* Presence of a concurrent bacterial infection requiring systemic therapy.\n* Significant immunocompromised, or severe/uncontrolled comorbid conditions.\n* History of hypersensitivity to any component of the investigational products.\n* Use of prohibited medications (including other anti-influenza antivirals) within a specified period prior to enrollment.\n* Recent participation in another interventional clinical trial.\n* Any condition that, in the opinion of the investigator, would jeopardize patient safety or compliance with the study protocol.'}, 'identificationModule': {'nctId': 'NCT07357051', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Joincare Pharmaceutical Group Industry Co., Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'JKN2301-III-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JKN2301 + Oseltamivir Placebo', 'interventionNames': ['Drug: JKN2301 Dry Suspension', 'Drug: Oseltamivir Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oseltamivir + JKN2301 Placebo', 'interventionNames': ['Drug: Oseltamivir', 'Drug: JKN2301 Placebo']}], 'interventions': [{'name': 'JKN2301 Dry Suspension', 'type': 'DRUG', 'description': 'Single oral dose, administered according to a weight-tiered dosing scheme.', 'armGroupLabels': ['JKN2301 + Oseltamivir Placebo']}, {'name': 'Oseltamivir Placebo', 'type': 'DRUG', 'description': 'Oral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir.', 'armGroupLabels': ['JKN2301 + Oseltamivir Placebo']}, {'name': 'Oseltamivir', 'type': 'DRUG', 'description': 'Oral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen.', 'armGroupLabels': ['Oseltamivir + JKN2301 Placebo']}, {'name': 'JKN2301 Placebo', 'type': 'DRUG', 'description': 'Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301.', 'armGroupLabels': ['Oseltamivir + JKN2301 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ying Yang', 'role': 'CONTACT', 'email': 'overseas@joincare.com', 'phone': '+86-0755-33268688'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joincare Pharmaceutical Group Industry Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}