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

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.

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.

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.