NCT07371650

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Traws Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	TRX-100	CEN inhibitor, dosage form - capsules, dosing regimen - QD
DRUG	Standard of Care (SOC)	Standard of Care Influenza Antiviral therapy

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2026-01-28
• Last updated: 2026-03-27

Locations

1 site across 1 country: Australia