Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:28 AM
Study NCT ID:
NCT07371650
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline in Viral Titer', 'timeFrame': 'up to Day 6', 'description': 'Change of virus titer compared to pretreatment baseline sample'}, {'measure': 'Change from Baseline in Viral Load', 'timeFrame': 'up to Day 6', 'description': 'Change in virus load compared to pretreatment baseline sample'}], 'primaryOutcomes': [{'measure': 'Incidence of AE/SAE', 'timeFrame': 'up to Day 28', 'description': 'Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)'}, {'measure': 'Incidence of abnormal laboratory tests results', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants with abnormal laboratory tests results'}, {'measure': 'Incidence of abnormal clinically significant ECG results', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of participants with abnormal physical examinations findings', 'timeFrame': 'Up to 28 days'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the total score of 7 influenza symptoms', 'timeFrame': 'up to Day 15', 'description': 'Seven symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue) will be assessed by the participant and recorded on a 4-point severity scale'}, {'measure': 'Plasma Tmax', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.', 'description': 'Time to reach the maximum plasma concentration of TRX-100.'}, {'measure': 'Incidence of influenza-related complications', 'timeFrame': 'Up to 28 days'}, {'measure': 'Time to alleviation of influenza clinical symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Time to resolution of fever to <37 C (axillary temperature)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Percentage of participants with resolution of fever', 'timeFrame': 'Up to 28 days'}, {'measure': 'Time needed to return to pre-influenza health status based on assessment of activities score', 'timeFrame': 'Up to 28 Days'}, {'measure': 'Plasma Cmax', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.', 'description': 'TRX-100 peak plasma concentration'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-100', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.'}, {'measure': 'Plasma Cmax', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.', 'description': 'TRX-101 peak plasma concentration'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.'}, {'measure': 'Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.', 'description': 'Area under the plasma concentration-time curve from time zero to 24 hours post-dose for TRX-100.'}, {'measure': 'Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)', 'timeFrame': 'PK samples will be collected from Day through Day 22', 'description': 'Area under the plasma concentration-time curve from time zero to 24 hours post-dose for TRX-101.'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinity', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.', 'description': 'A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-100.'}, {'measure': 'Area under the concentration-time curve extrapolated to infinity', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.', 'description': 'A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-101.'}, {'measure': 'Terminal elimination half-life', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.', 'description': 'The time required for the plasma concentration of TRX-100 to decrease by 50% in the terminal elimination phase.'}, {'measure': 'Terminal elimination half-life', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22', 'description': 'The time required for the plasma concentration of TRX-101 to decrease by 50% in the terminal elimination phase.'}, {'measure': 'Terminal elimination rate constant', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22', 'description': 'The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-100.'}, {'measure': 'Terminal elimination rate constant.', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22', 'description': 'The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-101.'}, {'measure': 'Apparent oral clearance (CL/F)', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22', 'description': 'Apparent total clearance of TRX-100 from plasma following oral administration'}, {'measure': 'Apparent oral clearance (CL/F)', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22', 'description': 'Apparent total clearance of TRX-101 from plasma following oral administration'}, {'measure': 'Apparent volume of distribution during the terminal phase', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.', 'description': 'Apparent volume of distribution of TRX-100 during the terminal elimination phase following oral administration, calculated as Clearance (CL/F) divided by the elimination rate constant.'}, {'measure': 'Apparent volume of distribution during the terminal phase', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.', 'description': 'Apparent volume of distribution of TRX-101 during the terminal elimination phase following oral administration, calculated as Clearance (CL/F) divided by the elimination rate constant.'}, {'measure': 'Plasma Tmax', 'timeFrame': 'Time Frame: PK samples will be collected from Day 1 through Day 22.', 'description': 'Time to reach the maximum plasma concentration of TRX-101.'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101.', 'timeFrame': 'PK samples will be collected from Day 1 through Day 22.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'This is an early-stage clinical trial to determine a safe and effective dose for Tivoxavir Marboxil (TRX-100) in patients with mild to moderate Influenza. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.', 'detailedDescription': 'This is a multicenter, open-label, randomized, Phase 2a study to evaluate the safety, tolerability, and pilot efficacy of different oral doses of TRX-100 in otherwise healthy participants with mild to moderate influenza. The study will also evaluate PK of TRX-100 and its major active metabolite, TRX-101, following single oral doses of TRX-100.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants with a diagnosis of influenza A or B virus infection\n* The time interval between the onset of symptoms and enrollment is 48 hours or less\n* Satisfactory baseline medical assessment by history and physical examination\n\nExclusion Criteria:\n\n* Positive test results for SARS-CoV-2 infection and/or respiratory syncytial virus infection\n* Participants with concurrent infections requiring systemic antimicrobial therapy\n* Participants with any serious or chronic underlying disease likely to affect study outcomes at the Investigator's discretion."}, 'identificationModule': {'nctId': 'NCT07371650', 'briefTitle': 'This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza', 'organization': {'class': 'INDUSTRY', 'fullName': 'Traws Pharma, Inc.'}, 'officialTitle': 'A Multicenter, Open-Label, Randomized Phase 2a Study to Evaluate the Safety and Efficacy of Different Oral Doses of TRX-100 and Standard of Care in Participants With Influenza', 'orgStudyIdInfo': {'id': 'TRX-100-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRX-100 Dose Level 1', 'description': 'Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100.', 'interventionNames': ['Drug: TRX-100']}, {'type': 'EXPERIMENTAL', 'label': 'TRX-100 Dose Level 2', 'description': 'Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100.', 'interventionNames': ['Drug: TRX-100']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care (SOC)', 'description': 'Participants in this arm will not receive the investigational drug. Instead, they will receive the current standard of care treatment. This arm serves as a comparator to evaluate the effects of the investigational drug.', 'interventionNames': ['Drug: Standard of Care (SOC)']}], 'interventions': [{'name': 'TRX-100', 'type': 'DRUG', 'description': 'CEN inhibitor, dosage form - capsules, dosing regimen - QD', 'armGroupLabels': ['TRX-100 Dose Level 1', 'TRX-100 Dose Level 2']}, {'name': 'Standard of Care (SOC)', 'type': 'DRUG', 'description': 'Standard of Care Influenza Antiviral therapy', 'armGroupLabels': ['Standard of Care (SOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2290', 'city': 'Charlestown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novatrials', 'geoPoint': {'lat': -32.96828, 'lon': 151.69318}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Traws Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}