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Clinical Trials in Australia / NCT07371650
Active, not recruiting Phase 2

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 · tracked via the Priya Life Science Australia tracker
Sponsor
Traws Pharma, Inc
Phase
Phase 2
Started
2025-12-15
Last updated
2026-03-27

Condition(s) studied

Influenza

Investigational drug(s) / intervention(s)

TRX-100 →Standard of Care (SOC)

TRX-100: CEN inhibitor, dosage form - capsules, dosing regimen - QD

Standard of Care (SOC): Standard of Care Influenza Antiviral therapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of AE/SAE — up to Day 28
    Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
  • Incidence of abnormal laboratory tests results — Up to Day 28
    Number of participants with abnormal laboratory tests results
  • Incidence of abnormal clinically significant ECG results — Up to 28 days
  • Number of participants with abnormal physical examinations findings — Up to 28 days

Trial sites (1)

FacilityCityRegionStatus
Novatrials Charlestown New South Wales

More Traws Pharma, Inc. trials in Australia

Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers Recruiting
Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19 Recruiting

Other trials for the same condition

A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06) Active, not recruiting
A Trial of RLX-2508-102 in Healthy Volunteers Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07371650 on ClinicalTrials.gov ↗ ← All trials in Australia