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

NCT07371650 | Active Not Recruiting Phase 2

• 1 other identifier: TRX-100-0002
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (25)

• Change from baseline in the total score of 7 influenza symptoms

  up to Day 15

• Plasma Tmax

  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

Other Outcomes (2)

• Change from Baseline in Viral Titer

  up to Day 6

• Change from Baseline in Viral Load

  up to Day 6

Study Arms (3)

TRX-100 Dose Level 1

EXPERIMENTAL

Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100.

Drug: TRX-100

TRX-100 Dose Level 2

EXPERIMENTAL

Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100.

Drug: TRX-100

Standard of Care (SOC)

ACTIVE COMPARATOR

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)

Interventions

TRX-100 DRUG

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

TRX-100 Dose Level 1; TRX-100 Dose Level 2

Standard of Care (SOC) DRUG

Standard of Care Influenza Antiviral therapy

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Traws Pharma, Inc.: lead

Study Sites (1)

Novatrials

Charlestown, New South Wales, 2290, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: January 28, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

AU (1)