Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model

ConditionInfluenza
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorTraws Pharma, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

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.

Trial design

Treatments tested in this trial

  • TRX-100
  • Placebo
  • Influenza A/France/759/2021 (H1N1) virus

Treatment groups

165 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators