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

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: Active, not recruiting
• Conditions: Influenza
• Intervention / Treatment: Drug: TRX-100; Drug: Standard of Care (SOC)

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: Interventional
• Enrollment (Estimated): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of AE/SAE	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	Number of participants with abnormal laboratory tests results	Up to Day 28
Incidence of abnormal clinically significant ECG results		Up to 28 days
Number of participants with abnormal physical examinations findings		Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the total score of 7 influenza symptoms	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 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		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)		Up to 28 days
Time to resolution of fever to <37 C (axillary temperature)		Up to 28 days
Percentage of participants with resolution of fever		Up to 28 days
Time needed to return to pre-influenza health status based on assessment of activities score		Up to 28 Days
Plasma Cmax	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		PK samples will be collected from Day 1 through Day 22.
Plasma Cmax	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		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)	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)	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	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	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	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	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	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.	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)	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)	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	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	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 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.		PK samples will be collected from Day 1 through Day 22.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Viral Titer	Change of virus titer compared to pretreatment baseline sample	up to Day 6
Change from Baseline in Viral Load	Change in virus load compared to pretreatment baseline sample	up to Day 6

Collaborators and Investigators

• Sponsor: Traws Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 4, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID 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