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NCT Number: NCT07371650

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novatrials

Charlestown, New South Wales, 2290, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRX-100

Drug

CEN inhibitor, dosage form - capsules, dosing regimen - QD

Standard of Care (SOC)

Drug

Standard of Care Influenza Antiviral therapy

Primary outcomes

  1. 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)

  2. Incidence of abnormal laboratory tests results

    Time frame: Up to Day 28

    Number of participants with abnormal laboratory tests results

  3. Incidence of abnormal clinically significant ECG results

    Time frame: Up to 28 days

  4. Number of participants with abnormal physical examinations findings

    Time frame: Up to 28 days

Secondary outcomes

  1. 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

  2. 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.

  3. Incidence of influenza-related complications

    Time frame: Up to 28 days

  4. 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

  5. Time to resolution of fever to <37 C (axillary temperature)

    Time frame: Up to 28 days

  6. Percentage of participants with resolution of fever

    Time frame: Up to 28 days

  7. Time needed to return to pre-influenza health status based on assessment of activities score

    Time frame: Up to 28 Days

  8. Plasma Cmax

    Time frame: PK samples will be collected from Day 1 through Day 22.

    TRX-100 peak plasma concentration

  9. 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.

  10. Plasma Cmax

    Time frame: PK samples will be collected from Day 1 through Day 22.

    TRX-101 peak plasma concentration

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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

  21. 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

  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.

  23. 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.

  24. 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.

  25. 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.

Other outcomes

  1. Change from Baseline in Viral Titer

    Time frame: up to Day 6

    Change of virus titer compared to pretreatment baseline sample

  2. Change from Baseline in Viral Load

    Time frame: up to Day 6

    Change in virus load compared to pretreatment baseline sample

Sponsors and collaborators

Lead sponsor

Traws Pharma, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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