This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza

March 26, 2026 updated by: Traws Pharma, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Charlestown, New South Wales, Australia, 2290
        • Novatrials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with a diagnosis of influenza A or B virus infection
  • The time interval between the onset of symptoms and enrollment is 48 hours or less
  • Satisfactory baseline medical assessment by history and physical examination

Exclusion Criteria:

  • Positive test results for SARS-CoV-2 infection and/or respiratory syncytial virus infection
  • Participants with concurrent infections requiring systemic antimicrobial therapy
  • Participants with any serious or chronic underlying disease likely to affect study outcomes at the Investigator's discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TRX-100 Dose Level 1
Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100.
Drug: TRX-100
CEN inhibitor, dosage form - capsules, dosing regimen - QD
Experimental: TRX-100 Dose Level 2
Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100.
Drug: TRX-100
CEN inhibitor, dosage form - capsules, dosing regimen - QD
Active Comparator: Standard of Care (SOC)
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.
Drug: Standard of Care (SOC)
Standard of Care Influenza Antiviral therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of AE/SAE
Time Frame: up to Day 28
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
up to Day 28
Incidence of abnormal laboratory tests results
Time Frame: Up to Day 28
Number of participants with abnormal laboratory tests results
Up to Day 28
Incidence of abnormal clinically significant ECG results
Time Frame: Up to 28 days
Up to 28 days
Number of participants with abnormal physical examinations findings
Time Frame: Up to 28 days
Up to 28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the total score of 7 influenza symptoms
Time Frame: up to Day 15
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
up to Day 15
Plasma Tmax
Time Frame: PK samples will be collected from Day 1 through Day 22.
Time to reach the maximum plasma concentration of TRX-100.
PK samples will be collected from Day 1 through Day 22.
Incidence of influenza-related complications
Time Frame: Up to 28 days
Up to 28 days
Time to alleviation of influenza clinical symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue)
Time Frame: Up to 28 days
Up to 28 days
Time to resolution of fever to <37 C (axillary temperature)
Time Frame: Up to 28 days
Up to 28 days
Percentage of participants with resolution of fever
Time Frame: Up to 28 days
Up to 28 days
Time needed to return to pre-influenza health status based on assessment of activities score
Time Frame: Up to 28 Days
Up to 28 Days
Plasma Cmax
Time Frame: PK samples will be collected from Day 1 through Day 22.
TRX-100 peak plasma concentration
PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-100
Time Frame: PK samples will be collected from Day 1 through Day 22.
PK samples will be collected from Day 1 through Day 22.
Plasma Cmax
Time Frame: PK samples will be collected from Day 1 through Day 22.
TRX-101 peak plasma concentration
PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101
Time Frame: PK samples will be collected from Day 1 through Day 22.
PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
Time Frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to 24 hours post-dose for TRX-100.
PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
Time Frame: PK samples will be collected from Day through Day 22
Area under the plasma concentration-time curve from time zero to 24 hours post-dose for TRX-101.
PK samples will be collected from Day through Day 22
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time Frame: PK samples will be collected from Day 1 through Day 22.
A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-100.
PK samples will be collected from Day 1 through Day 22.
Area under the concentration-time curve extrapolated to infinity
Time Frame: PK samples will be collected from Day 1 through Day 22.
A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-101.
PK samples will be collected from Day 1 through Day 22.
Terminal elimination half-life
Time Frame: PK samples will be collected from Day 1 through Day 22.
The time required for the plasma concentration of TRX-100 to decrease by 50% in the terminal elimination phase.
PK samples will be collected from Day 1 through Day 22.
Terminal elimination half-life
Time Frame: PK samples will be collected from Day 1 through Day 22
The time required for the plasma concentration of TRX-101 to decrease by 50% in the terminal elimination phase.
PK samples will be collected from Day 1 through Day 22
Terminal elimination rate constant
Time Frame: PK samples will be collected from Day 1 through Day 22
The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-100.
PK samples will be collected from Day 1 through Day 22
Terminal elimination rate constant.
Time Frame: PK samples will be collected from Day 1 through Day 22
The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-101.
PK samples will be collected from Day 1 through Day 22
Apparent oral clearance (CL/F)
Time Frame: PK samples will be collected from Day 1 through Day 22
Apparent total clearance of TRX-100 from plasma following oral administration
PK samples will be collected from Day 1 through Day 22
Apparent oral clearance (CL/F)
Time Frame: PK samples will be collected from Day 1 through Day 22
Apparent total clearance of TRX-101 from plasma following oral administration
PK samples will be collected from Day 1 through Day 22
Apparent volume of distribution during the terminal phase
Time Frame: PK samples will be collected from Day 1 through Day 22.
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.
PK samples will be collected from Day 1 through Day 22.
Apparent volume of distribution during the terminal phase
Time Frame: PK samples will be collected from Day 1 through Day 22.
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.
PK samples will be collected from Day 1 through Day 22.
Plasma Tmax
Time Frame: Time Frame: PK samples will be collected from Day 1 through Day 22.
Time to reach the maximum plasma concentration of TRX-101.
Time Frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101.
Time Frame: PK samples will be collected from Day 1 through Day 22.
PK samples will be collected from Day 1 through Day 22.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Viral Titer
Time Frame: up to Day 6
Change of virus titer compared to pretreatment baseline sample
up to Day 6
Change from Baseline in Viral Load
Time Frame: up to Day 6
Change in virus load compared to pretreatment baseline sample
up to Day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Traws Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRX-100-0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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