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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
TRX-100
DrugA single oral dose in capsules
Placebo
DrugA single oral dose in capsules
Influenza A/France/759/2021 (H1N1) virus
Biological/VaccineA single dose of challenge agent will be delivered Intranasal
Treatment groups
165 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: TRX-100 Timing 1Experimental treatment 2 interventions
Group B: TRX-100 Timing 2Experimental treatment 2 interventions
Group C: TRX-100 Timing 3Experimental treatment 2 interventions
Group D: TRX-100 Timing 4Experimental treatment 2 interventions
Group E: Placebo Timing 1Placebo comparator 2 interventions
Group F: Placebo Timing 2Placebo comparator 2 interventions
Group G: Placebo Timing 3Placebo comparator 2 interventions
Group H: Placebo Timing 4Placebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Laboratory-Confirmed Infection
Defined as at least 2 quantifiable (≥LLOQ) qRT-PCR samples reported over 4 planned consecutive assessments within 48 hours.
Time frame
From Day 1 (pm) up to Day 8 (am)2
Symptoms of Grade ≥2
At least one incidence of a symptom from the symptom diary card of grade ≥2.
Time frame
From Day 1 (am) to Day 8 (am)Secondary outcomes
1
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.
Time frame
From Day 1 (pm) to Day 8 (am)2
Viral Load Area Under the Curve by Viral Culture
VL AUC of influenza virus as determined by viral culture in nasal samples.
Time frame
From Day 1 (pm) to Day 8 (am)3
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.
Time frame
From Day 1 (pm) to Day 8 (am)4
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.
Time frame
From Day 1 (pm) to Day 8 (am)Sponsors and contacts
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Source ClinicalTrials.gov
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