Phase 2a study of the efficacy and safety of TRX-100 in a human influenza challenge model

• Research type

  Research Study

• Full title

  A PHASE 2A, SINGLE-CENTER, RANDOMIZED, DOUBLE- BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TIVOXAVIR MARBOXIL (TRX-100) IN HEALTHY ADULTS IN A HUMAN INFLUENZA A CHALLENGE MODEL

• IRAS ID

  1013796

• Contact name

  Dr. David Pauza

• Contact email

  cdpauza@trawspharma.com

• Sponsor organisation

  Traws Pharma, Inc.

• Research summary

  This study will test whether a single dose of an experimental antiviral medical called Tivoxavir Marboxil (TRX-100) can help prevent flu when healthy volunteers are deliberately exposed to influenza A virus. Participants aged 18-55 years will take TRX-100 or placebo by mouth up to 28 days before given flu virus via nasal drops in a specialist quarantine unit, where they will be closely monitored for about 10 days. The study will measure whether TRX-100 reduces the number of people who develop laboratory- confirmed flu illness, viral load, and symptom scores, whilst checking the medicines is safe and well tolerated.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  26/WM/0084

• Date of REC Opinion

  8 Jun 2026

• REC opinion

  Further Information Unfavourable Opinion