Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model (NCT07503405) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model
United Kingdom165 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Females of childbearing potential must have a negative pregnancy test prior to enrollment.
✓. Females of non-childbearing potential:
Exclusion criteria
✕. 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.
✕. 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.