InfluenzaPhase 2NCT07503405
Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model
A Phase 2 study testing TRX-100 and Influenza A/France/759/2021 (H1N1) virus in people with Influenza, run by Traws Pharma, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- TRX-100 and Influenza A/France/759/2021 (H1N1) virus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2026to Apr 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent signed and dated by the participant and the PI/investigator obtained before any assessment is performed.
- Aged between 18 and 55 years old on the day prior to signing the consent form, inclusive.
- A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2.
- In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the PI/investigator.
- Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening.
- The following criteria are applicable to female participants participating in the study:
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- Females of childbearing potential must have a negative pregnancy test prior to enrollment.
- Females of non-childbearing potential:
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- Postmenopausal females defined as amenorrhea for 12 months or greater with no alternative medical cause. A high follicle-stimulating hormone (FSH) level, within appropriate postmenopausal range, may be used to confirm postmenopausal state in the absence of combined hormonal contraception or hormone replacement therapy. If there is less than 12 months of amenorrhea 2 FSH samples are required at least 4 to 6 weeks apart.
- Documented status as being permanently sterile (e.g., hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
- Female participants of childbearing potential must use one form of highly effective contraception (birth control). Hormonal methods must be in place from at least 2 weeks prior to the first study visit (IMP administration visit). The contraception use must continue until 28 days after the date of challenge agent administration.
- Male participants must agree to use one of the contraceptive requirements below from the first study visit and continuing until 28 days after the date of challenge agent administration.
- Serosuitable for the challenge agent. The serology result obtained from the influenza antibody assay suggests that the participant is sensitive to influenza infection (i.e., they are likely to be infected following inoculation with the challenge agent).
Who cannot join
- History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT or LRT) infection within 4 weeks prior to the first study visit.
- Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, hematologic, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease that, in the opinion of the PI/investigator, may interfere with a participant completing the study and necessary investigations. The following conditions apply:
- Participants with a history of resolved depression and/or anxiety may be included at the discretion of the PI/investigator. Participants with a history of stress-related illness, which is not ongoing or requiring current therapy, with good evidence of preceding stressors may also be included at the PI/investigator's discretion. As required, participants will be assessed prior to enrollment with a Patient Health Questionnaire (PHQ)-9 and/or Generalized Anxiety Disorder (GAD)-7 questionnaire which must score ≤4 on admission.
- Rhinitis (including hay fever) which is clinically active or a history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine will be excluded. Participants with a history of currently inactive rhinitis (within the last 30 days) or mild rhinitis may be included at the PI/investigator's discretion.
- Atopic dermatitis/eczema which is clinically severe and/or requiring moderate to large amounts of daily dermal corticosteroids will be excluded. Participants with mild to moderate atopic dermatitis/eczema, taking small amounts of regular dermal corticosteroids may be included at the PI/investigator's discretion.
- Any concurrent serious illness including history of malignancy that may interfere with a participant completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion.
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- Participants reporting physician-diagnosed migraine can be included provided there are no associated neurological symptoms such as hemiplegia or visual loss. Cluster headache/migraine or prophylactic treatment for migraine is an exclusion.
- Participants with physician-diagnosed mild irritable bowel syndrome not requiring regular treatment can be included at the PI/investigator's discretion.
- Any participants who have smoked ≥10 pack years at any time (10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years) including (as applicable) any calculable or self-reported significant vaping history.
- Females who:
- Are breastfeeding, or
- Have been pregnant within 6 months prior to the study, or
- Have a positive pregnancy test at any point during screening or prior to dosing with IMP.
- Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction. Significant intolerance to any food or drug in the last 12 months, as assessed by the PI/investigator.
- Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
- a) Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and, in particular, any of the nasal assessments or challenge agent administration (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded).
- Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalized due to epistaxis on any previous occasion.
- Any nasal or sinus surgery within 3 months of the first study visit.
- a) Evidence of vaccinations within the 4 weeks prior to the planned date of dosing with IMP.
- Intention to receive any vaccination(s) before the last day of follow-up. c) Receipt of influenza vaccine in the last 180 days prior to the planned date of viral challenge.
- Received antiviral medication for influenza in the last 180 days prior to the planned date of viral challenge.
- Having had confirmed influenza illness in the last 180 days prior to the planned dosing of IMP.
- Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned date of dosing with IMP or planned during the 3 months after the final follow-up visit.
- a) Receipt of any investigational drug within 3 months or 5 half-lives (whichever is greater) prior to the planned date of dosing with IMP.
- Receipt of ≥3 investigational drugs within the previous 12 months prior to the planned date of dosing with IMP.
- Prior inoculation with a virus from the same virus-family as the challenge agent.
- Prior participation in another human challenge study with a challenge agent in the preceding 3 months, taken from the date of challenge agent administration in the previous study to the date of expected challenge agent administration in this study.
- Use or anticipated use during the conduct of the study of concomitant medications (prescription and/or non-prescription), including vitamins or herbal and dietary supplements within the specified windows, unless in the opinion of the PI/investigator, the medication will not interfere with the study procedures or compromise participant safety. Specifically, the following are excluded:
- Herbal supplements within 7 days prior to the planned date of dosing with IMP.
- Chronically used medications, vitamins, or dietary supplements, including any medications known to be potent inducers or inhibitors of CYP450 enzymes, within 21 days prior to the planned date of dosing with IMP.
- Over the counter medications (e.g., paracetamol or ibuprofen) where the dose taken over the preceding 7 days prior to the planned date of dosing with IMP has exceeded the maximum permissible 24-hour dose (e.g., ≥4 g paracetamol over the preceding week).
- Systemic antiviral administration within 4 weeks of the dosing with IMP.
- a) Confirmed positive test for drugs of misuse on first study visit (i.e., IMP administration visit). One repeat test is allowed at PI/investigator's discretion.
- Recent history or presence of alcohol addiction, or excessive use of alcohol (weekly intake in excess of 28 units alcohol; 1 unit being a half glass of beer, a small glass of wine or a measure of spirits).
- Excessive consumption of xanthine-containing substances (e.g., daily intake in excess of 5 cups of caffeinated drinks e.g., coffee, tea, cola).
- Presence of significant signs and symptoms of nicotine withdrawal on entry to the clinical unit.
- A forced expiratory volume in 1 second (FEV1) < 80%.
- Positive HIV, hepatitis B, or hepatitis C test.
- Presence of fever, defined as participant presenting with a temperature reading of ≥37.9ºC on Day -2, Day -1, and/or pre-challenge on Day 0.
- Those employed or immediate relatives of those employed at hVIVO or the sponsor.
- Any other medical, psychiatric, social, or occupational condition and/or responsibility that, in the opinion of the PI/investigator, would interfere with, or serve as a contraindication to, protocol adherence or the assessment of safety (including reactogenicity) will deem the participant unsuitable for the study.
- Any other reason that in the opinion of the PI/investigator raises a concern that the participant will not be able to cope with quarantine requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
hVIVO Services Limited
London, E14 5NR
Alexander Lima, Dr., +44 (0)7990 364840, a.lima@hvivo.com
About this study
Official title: 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
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.
Read the 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
- Being tested
- TRX-100, Placebo, Influenza A/France/759/2021 (H1N1) virus
- Keywords
- Challenge study
- 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
A single oral dose in capsules
PlaceboDrug
A single oral dose in capsules
Influenza A/France/759/2021 (H1N1) virusBiological
A single dose of challenge agent will be delivered Intranasal
| Study group | Role | What they receive |
|---|---|---|
| TRX-100 Timing 1 | Experimental | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. Receives: Drug: TRX-100; Biological: Influenza A/France/759/2021 (H1N1) virus |
| TRX-100 Timing 2 | Experimental | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. Receives: Drug: TRX-100; Biological: Influenza A/France/759/2021 (H1N1) virus |
| TRX-100 Timing 3 | Experimental | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. Receives: Drug: TRX-100; Biological: Influenza A/France/759/2021 (H1N1) virus |
| TRX-100 Timing 4 | Experimental | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. Receives: Drug: TRX-100; Biological: Influenza A/France/759/2021 (H1N1) virus |
| Placebo Timing 1 | Placebo comparator | Participants in this arm will receive single oral dose of the Placebo. Receives: Drug: Placebo; Biological: Influenza A/France/759/2021 (H1N1) virus |
| Placebo Timing 2 | Placebo comparator | Participants in this arm will receive single oral dose of the Placebo. Receives: Drug: Placebo; Biological: Influenza A/France/759/2021 (H1N1) virus |
| Placebo Timing 3 | Placebo comparator | Participants in this arm will receive single oral dose of the Placebo. Receives: Drug: Placebo; Biological: Influenza A/France/759/2021 (H1N1) virus |
| Placebo Timing 4 | Placebo comparator | Participants in this arm will receive single oral dose of the Placebo. Receives: Drug: Placebo; Biological: Influenza A/France/759/2021 (H1N1) virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory-Confirmed Infection
Defined as at least 2 quantifiable (≥LLOQ) qRT-PCR samples reported over 4 planned consecutive assessments within 48 hours.
Measured: From Day 1 (pm) up to Day 8 (am)
Symptoms of Grade ≥2
At least one incidence of a symptom from the symptom diary card of grade ≥2.
Measured: From Day 1 (am) to Day 8 (am)
Secondary outcomes (17)
Area Under the Viral Load-Time Curve
Area under the viral load-time curve (VL AUC) of influenza virus as determined by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) in nasal samples.
Measured: From Day 1 (pm) to Day 8 (am)
Viral Load Area Under the Curve by Viral Culture
VL AUC of influenza virus as determined by viral culture in nasal samples.
Measured: From Day 1 (pm) to Day 8 (am)
Peak Viral Load by qRT-PCR
VLPEAK of influenza virus as defined by the maximum viral load determined by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) in nasal samples.
Measured: From Day 1 (pm) to Day 8 (am)
Peak Viral Load (VLPEAK) by Viral Culture
VLPEAK of influenza virus as defined by the maximum viral load determined by viral culture in nasal samples.
Measured: From Day 1 (pm) to Day 8 (am)
Time to Viral Clearance by qRT-PCR
Time to resolution from first quantifiable (≥LLOQ) assessment (as determined by quantitative reverse transcription-polymerase chain reaction [qRT-PCR] in nasal samples), defined as the time (hours) from first quantifiable assessment until the first confirmed unquantifiable assessment (after which no further virus is quantified).
Measured: From Day 1 (pm) to Day 8 (am)
Time to Viral Clearance by Viral Culture
Time to resolution from first quantifiable (≥LLOQ) assessment (as determined by viral culture measurements on nasal samples), defined as the time (hours) from first quantifiable assessment until the first confirmed unquantifiable assessment.
Measured: From Day 1 (pm) to Day 8 (am)
Area Under the Total Symptom Score-Time Curve
Area under the total symptoms score-time curve as measured by graded symptom scoring system collected 3 times daily.
Measured: From Day 1 (am) to Day 8 (am)
Peak Total Symptom Score
Peak total symptom score (Peak TSS) as measured by graded symptom scoring system collected 3 times daily.
Measured: From Day 1 (am) to Day 8 (am)
Peak Daily Symptom Score
Peak daily symptom score: individual maximum daily sum of symptom score.
Measured: From Day 1 (am) to Day 8 (am)
Time to Symptom Resolution from Onset
Time to resolution from onset of symptoms is defined as the time (hours) from first occurrence of any symptoms to first 24-hour period without symptoms after the peak TSS (after which no further symptoms occur).
Measured: From first occurrence of symptoms until first 24-hour symptom-free period after peak TSS.
Time to Resolution of Grade ≥2 Symptoms
Time to resolution of grade ≥2 symptoms from the symptom diary card, defined as the time (days) from first occurrence of any grade ≥2 symptom to first 24-hour period without grade ≥2 symptoms after peak TSS (after which no further grade ≥2 symptoms occur).
Measured: From first grade ≥2 symptom to first 24-hour period without grade ≥2 symptoms after peak TSS
Incidence of Laboratory-Confirmed Infection
Measured: From Day 1 (pm) up to Day 8 (am)
Incidence of Laboratory-Confirmed Mild Symptomatic Disease
Measured: From Day 1 (am) up to Day 8 (am)
Incidence of Laboratory-Confirmed Febrile Infection
Measured: From Day 1 (am) to Day 8 (am)
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Measured: From first IMP administration up to Day 28 (±3 days) follow-up visit
Incidence of (S)AEs Related to Viral Challenge
Measured: From viral challenge (Day 0) up to Day 28 (±3 days) follow-up visit
Use of Concomitant Medications
Measured: From Day 0 up to Day 28 (±3 days) follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionApr 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 165 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
- NCT07503405
- Sponsor's protocol ID
- TRX-100-0004
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07503405
- Acronym / sponsor ID
- TRX-100-0004
- Conditions
- Influenza
- Keywords
- Challenge study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Traws Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 31 Mar 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| TRX-100 Timing 1 | Experimental | Drug: TRX-100, Biological: Influenza A/France/759/2021 (H1N1) virusParticipants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 2 | Experimental | Drug: TRX-100, Biological: Influenza A/France/759/2021 (H1N1) virusParticipants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 3 | Experimental | Drug: TRX-100, Biological: Influenza A/France/759/2021 (H1N1) virusParticipants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 4 | Experimental | Drug: TRX-100, Biological: Influenza A/France/759/2021 (H1N1) virusParticipants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| Placebo Timing 1 | Placebo comparator | Drug: Placebo, Biological: Influenza A/France/759/2021 (H1N1) virusParticipants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 2 | Placebo comparator | Drug: Placebo, Biological: Influenza A/France/759/2021 (H1N1) virusParticipants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 3 | Placebo comparator | Drug: Placebo, Biological: Influenza A/France/759/2021 (H1N1) virusParticipants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 4 | Placebo comparator | Drug: Placebo, Biological: Influenza A/France/759/2021 (H1N1) virusParticipants in this arm will receive single oral dose of the Placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Written informed consent signed and dated by the participant and the PI/investigator obtained before any assessment is performed.
- Aged between 18 and 55 years old on the day prior to signing the consent form, inclusive.
- A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2.
- In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the PI/investigator.
- Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening.
Key exclusion criteria (42 listed)
- History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT or LRT) infection within 4 weeks prior to the first study visit.
- Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, hematologic, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease that, in the opinion of the PI/investigator, may interfere with a participant completing the study and necessary investigations. The following conditions apply:
- Any participants who have smoked ≥10 pack years at any time (10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years) including (as applicable) any calculable or self-reported significant vaping history.
- Females who:
- Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction. Significant intolerance to any food or drug in the last 12 months, as assessed by the PI/investigator.
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-100A single oral dose in capsules | Drug | TRX-100 Timing 1, TRX-100 Timing 2, TRX-100 Timing 3, TRX-100 Timing 4 |
| PlaceboA single oral dose in capsules | Drug | Placebo Timing 1, Placebo Timing 2, Placebo Timing 3, Placebo Timing 4 |
| Influenza A/France/759/2021 (H1N1) virusA single dose of challenge agent will be delivered Intranasal | Biological | Placebo Timing 1, Placebo Timing 2, Placebo Timing 3, Placebo Timing 4, TRX-100 Timing 1, TRX-100 Timing 2, TRX-100 Timing 3, TRX-100 Timing 4 |
Primary outcome
Laboratory-Confirmed Infection
Time frame: From Day 1 (pm) up to Day 8 (am)
Defined as at least 2 quantifiable (≥LLOQ) qRT-PCR samples reported over 4 planned consecutive assessments within 48 hours.
Symptoms of Grade ≥2
Time frame: From Day 1 (am) to Day 8 (am)
At least one incidence of a symptom from the symptom diary card of grade ≥2.
17 secondary outcomes
Area Under the Viral Load-Time Curve
Time frame: From Day 1 (pm) to Day 8 (am)
Viral Load Area Under the Curve by Viral Culture
Time frame: From Day 1 (pm) to Day 8 (am)
Peak Viral Load by qRT-PCR
Time frame: From Day 1 (pm) to Day 8 (am)
Peak Viral Load (VLPEAK) by Viral Culture
Time frame: From Day 1 (pm) to Day 8 (am)
Time to Viral Clearance by qRT-PCR
Time frame: From Day 1 (pm) to Day 8 (am)
Time to Viral Clearance by Viral Culture
Time frame: From Day 1 (pm) to Day 8 (am)
Area Under the Total Symptom Score-Time Curve
Time frame: From Day 1 (am) to Day 8 (am)
Peak Total Symptom Score
Time frame: From Day 1 (am) to Day 8 (am)
Peak Daily Symptom Score
Time frame: From Day 1 (am) to Day 8 (am)
Time to Symptom Resolution from Onset
Time frame: From first occurrence of symptoms until first 24-hour symptom-free period after peak TSS.
Time to Resolution of Grade ≥2 Symptoms
Time frame: From first grade ≥2 symptom to first 24-hour period without grade ≥2 symptoms after peak TSS
Incidence of Laboratory-Confirmed Infection
Time frame: From Day 1 (pm) up to Day 8 (am)
Incidence of Laboratory-Confirmed Mild Symptomatic Disease
Time frame: From Day 1 (am) up to Day 8 (am)
Incidence of Laboratory-Confirmed Febrile Infection
Time frame: From Day 1 (am) to Day 8 (am)
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first IMP administration up to Day 28 (±3 days) follow-up visit
Incidence of (S)AEs Related to Viral Challenge
Time frame: From viral challenge (Day 0) up to Day 28 (±3 days) follow-up visit
Use of Concomitant Medications
Time frame: From Day 0 up to Day 28 (±3 days) follow-up visit
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 31 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 and Influenza A/France/759/2021 (H1N1) virus in people with Influenza, run by Traws Pharma, Inc. at 1 site in United Kingdom.
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 14 inclusion and 42 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: opening soon, as of the sponsor's last update on 31 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Contact Ekaterina Dokukina (+38269728309, kdokukina@eilenther.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory-Confirmed Infection (time frame: From Day 1 (pm) up to Day 8 (am)). The study lists 2 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 31 Mar 2026.