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

Traws Pharma, Inc.

Status and phase: Active, not recruiting; Phase 2

Conditions: Influenza

Treatments: Drug: TRX-100; Drug: Standard of Care (SOC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07371650

TRX-100-0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

TRX-100 Dose Level 1

Experimental group

Description:

Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100.

Treatment:

Drug: TRX-100

TRX-100 Dose Level 2

Experimental group

Description:

Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100.

Treatment:

Drug: TRX-100

Standard of Care (SOC)

Active Comparator group

Description:

Participants in this arm will not receive the investigational drug. Instead, they will receive the current standard of care treatment. This arm serves as a comparator to evaluate the effects of the investigational drug.

Treatment:

Drug: Standard of Care (SOC)