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

NCT07503405 | Not Yet Recruiting Phase 2

• 1 other identifier: TRX-100-0004
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Keywords

Challenge study

Outcome Measures

Primary Outcomes (2)

• Laboratory-Confirmed Infection

  Defined as at least 2 quantifiable (≥LLOQ) qRT-PCR samples reported over 4 planned consecutive assessments within 48 hours.

  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.

  From Day 1 (am) to Day 8 (am)

Secondary Outcomes (17)

• Area Under the Viral Load-Time Curve

  From Day 1 (pm) to Day 8 (am)

• Viral Load Area Under the Curve by Viral Culture

  From Day 1 (pm) to Day 8 (am)

• Peak Viral Load by qRT-PCR

  From Day 1 (pm) to Day 8 (am)

• Peak Viral Load (VLPEAK) by Viral Culture

  From Day 1 (pm) to Day 8 (am)

• Time to Viral Clearance by qRT-PCR

  From Day 1 (pm) to Day 8 (am)

Study Arms (8)

TRX-100 Timing 1

EXPERIMENTAL

Participants in this arm will receive single oral dose of the investigational drug, TRX-100.

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.

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.

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.

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.

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.

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.

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.

Drug: Placebo; Biological: Influenza A/France/759/2021 (H1N1) virus

Interventions

TRX-100 DRUG

A single oral dose in capsules

TRX-100 Timing 1; TRX-100 Timing 2; TRX-100 Timing 3; TRX-100 Timing 4

Placebo DRUG

A single oral dose in capsules

Placebo Timing 1; Placebo Timing 2; Placebo Timing 3; Placebo Timing 4

Influenza A/France/759/2021 (H1N1) virus BIOLOGICAL

A single dose of challenge agent will be delivered Intranasal

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
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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).

You may not qualify if:

• 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.
• 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.
• 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).
• b) 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.
• c) Any nasal or sinus surgery within 3 months of the first study visit.

Sponsors & Collaborators

• Traws Pharma, Inc.: lead

Study Sites (1)

hVIVO Services Limited

London, E14 5NR, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Ekaterina Dokukina

CONTACT

+38269728309; kdokukina@eilenther.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)