NCT07503405

Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Traws Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be a randomized, double-blind, placebo-controlled proof of concept study to evaluate the prophylactic efficacy and safety of orally administered TRX-100 in healthy adults challenged with influenza A/France/759/2021 (H1N1) virus.

Detailed description

This is a Phase 2a study in healthy adult participants between 18 and 55 years of age. Study design is a single-center, randomized, double-blind, placebo-controlled study to evaluate the prophylactic efficacy and safety of TRX-100 followed by inoculation with influenza A challenge agent in healthy adults.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	TRX-100	A single oral dose in capsules
DRUG	Placebo	A single oral dose in capsules
BIOLOGICAL	Influenza A/France/759/2021 (H1N1) virus	A single dose of challenge agent will be delivered Intranasal

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-11-01
• Completion: 2027-04-01
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: United Kingdom