InfluenzaPhase 2NCT07371650
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 Phase 2 study testing TRX-100 in people with Influenza, run by Traws Pharma, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Influenza
- What is being tested?
- TRX-100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Dec 2025to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- TRX-100, Standard of Care (SOC)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRX-100Drug
CEN inhibitor, dosage form - capsules, dosing regimen - QD
Standard of Care (SOC)Drug
Standard of Care Influenza Antiviral therapy
| Study group | Role | What they receive |
|---|---|---|
| TRX-100 Dose Level 1 | Experimental | Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100. Receives: Drug: TRX-100 |
| TRX-100 Dose Level 2 | Experimental | Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100. Receives: Drug: TRX-100 |
| Standard of Care (SOC) | Active comparator | 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. Receives: Drug: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AE/SAE
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
Measured: up to Day 28
Incidence of abnormal laboratory tests results
Number of participants with abnormal laboratory tests results
Measured: Up to Day 28
Incidence of abnormal clinically significant ECG results
Measured: Up to 28 days
Number of participants with abnormal physical examinations findings
Measured: Up to 28 days
Secondary outcomes (25)
Change from baseline in the total score of 7 influenza symptoms
Seven symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue) will be assessed by the participant and recorded on a 4-point severity scale
Measured: up to Day 15
Plasma Tmax
Time to reach the maximum plasma concentration of TRX-100.
Measured: PK samples will be collected from Day 1 through Day 22.
Incidence of influenza-related complications
Measured: Up to 28 days
Time to alleviation of influenza clinical symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue)
Measured: Up to 28 days
Time to resolution of fever to <37 C (axillary temperature)
Measured: Up to 28 days
Percentage of participants with resolution of fever
Measured: Up to 28 days
Time needed to return to pre-influenza health status based on assessment of activities score
Measured: Up to 28 Days
Plasma Cmax
TRX-100 peak plasma concentration
Measured: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-100
Measured: PK samples will be collected from Day 1 through Day 22.
Plasma Cmax
TRX-101 peak plasma concentration
Measured: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101
Measured: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
Area under the plasma concentration-time curve from time zero to 24 hours post-dose for TRX-100.
Measured: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
Area under the plasma concentration-time curve from time zero to 24 hours post-dose for TRX-101.
Measured: PK samples will be collected from Day through Day 22
Area under the plasma concentration-time curve from time zero extrapolated to infinity
A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-100.
Measured: PK samples will be collected from Day 1 through Day 22.
Area under the concentration-time curve extrapolated to infinity
A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-101.
Measured: PK samples will be collected from Day 1 through Day 22.
Terminal elimination half-life
The time required for the plasma concentration of TRX-100 to decrease by 50% in the terminal elimination phase.
Measured: PK samples will be collected from Day 1 through Day 22.
Terminal elimination half-life
The time required for the plasma concentration of TRX-101 to decrease by 50% in the terminal elimination phase.
Measured: PK samples will be collected from Day 1 through Day 22
Terminal elimination rate constant
The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-100.
Measured: PK samples will be collected from Day 1 through Day 22
Terminal elimination rate constant.
The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-101.
Measured: PK samples will be collected from Day 1 through Day 22
Apparent oral clearance (CL/F)
Apparent total clearance of TRX-100 from plasma following oral administration
Measured: PK samples will be collected from Day 1 through Day 22
Apparent oral clearance (CL/F)
Apparent total clearance of TRX-101 from plasma following oral administration
Measured: PK samples will be collected from Day 1 through Day 22
Apparent volume of distribution during the terminal phase
Apparent volume of distribution of TRX-100 during the terminal elimination phase following oral administration, calculated as Clearance (CL/F) divided by the elimination rate constant.
Measured: PK samples will be collected from Day 1 through Day 22.
Apparent volume of distribution during the terminal phase
Apparent volume of distribution of TRX-101 during the terminal elimination phase following oral administration, calculated as Clearance (CL/F) divided by the elimination rate constant.
Measured: PK samples will be collected from Day 1 through Day 22.
Plasma Tmax
Time to reach the maximum plasma concentration of TRX-101.
Measured: Time Frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101.
Measured: PK samples will be collected from Day 1 through Day 22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start15 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Traws Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371650
- Sponsor's protocol ID
- TRX-100-0002
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07371650
- Acronym / sponsor ID
- TRX-100-0002
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Traws Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy
| Arm | Type | Receives |
|---|---|---|
| TRX-100 Dose Level 1 | Experimental | Drug: TRX-100Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100. |
| TRX-100 Dose Level 2 | Experimental | Drug: TRX-100Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100. |
| Standard of Care (SOC) | Active comparator | Drug: Standard of Care (SOC)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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRX-100CEN inhibitor, dosage form - capsules, dosing regimen - QD | Drug | TRX-100 Dose Level 1, TRX-100 Dose Level 2 |
| Standard of Care (SOC)Standard of Care Influenza Antiviral therapy | Drug | Standard of Care (SOC) |
Primary outcome
Incidence of AE/SAE
Time frame: up to Day 28
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
Incidence of abnormal laboratory tests results
Time frame: Up to Day 28
Number of participants with abnormal laboratory tests results
Incidence of abnormal clinically significant ECG results
Time frame: Up to 28 days
Number of participants with abnormal physical examinations findings
Time frame: Up to 28 days
25 secondary outcomes
Change from baseline in the total score of 7 influenza symptoms
Time frame: up to Day 15
Plasma Tmax
Time frame: PK samples will be collected from Day 1 through Day 22.
Incidence of influenza-related complications
Time frame: Up to 28 days
Time to alleviation of influenza clinical symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue)
Time frame: Up to 28 days
Time to resolution of fever to <37 C (axillary temperature)
Time frame: Up to 28 days
Percentage of participants with resolution of fever
Time frame: Up to 28 days
Time needed to return to pre-influenza health status based on assessment of activities score
Time frame: Up to 28 Days
Plasma Cmax
Time frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-100
Time frame: PK samples will be collected from Day 1 through Day 22.
Plasma Cmax
Time frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101
Time frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
Time frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
Time frame: PK samples will be collected from Day through Day 22
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: PK samples will be collected from Day 1 through Day 22.
Area under the concentration-time curve extrapolated to infinity
Time frame: PK samples will be collected from Day 1 through Day 22.
Terminal elimination half-life
Time frame: PK samples will be collected from Day 1 through Day 22.
Terminal elimination half-life
Time frame: PK samples will be collected from Day 1 through Day 22
Terminal elimination rate constant
Time frame: PK samples will be collected from Day 1 through Day 22
Terminal elimination rate constant.
Time frame: PK samples will be collected from Day 1 through Day 22
Apparent oral clearance (CL/F)
Time frame: PK samples will be collected from Day 1 through Day 22
Apparent oral clearance (CL/F)
Time frame: PK samples will be collected from Day 1 through Day 22
Apparent volume of distribution during the terminal phase
Time frame: PK samples will be collected from Day 1 through Day 22.
Apparent volume of distribution during the terminal phase
Time frame: PK samples will be collected from Day 1 through Day 22.
Plasma Tmax
Time frame: Time Frame: PK samples will be collected from Day 1 through Day 22.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101.
Time frame: PK samples will be collected from Day 1 through Day 22.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRX-100 in people with Influenza, run by Traws Pharma, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AE/SAE (time frame: up to Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.