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

Sponsor
Traws Pharma, Inc.
Study ID
NCT07503405
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • TRX-100 — DRUG
    A single oral dose in capsules
  • Placebo — DRUG
    A single oral dose in capsules
  • Influenza A/France/759/2021 (H1N1) virus — BIOLOGICAL
    A single dose of challenge agent will be delivered Intranasal

Study Details

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.

Key Dates

First listed
Mar 31, 2026
Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: TRX-100 Timing 1
    Participants in this arm will receive single oral dose of the investigational drug, TRX-100.
  • Experimental: TRX-100 Timing 2
    Participants in this arm will receive single oral dose of the investigational drug, TRX-100.
  • Experimental: TRX-100 Timing 3
    Participants in this arm will receive single oral dose of the investigational drug, TRX-100.
  • Experimental: TRX-100 Timing 4
    Participants in this arm will receive single oral dose of the investigational drug, TRX-100.
  • Placebo Comparator: Placebo Timing 1
    Participants in this arm will receive single oral dose of the Placebo.
  • Placebo Comparator: Placebo Timing 2
    Participants in this arm will receive single oral dose of the Placebo.
  • Placebo Comparator: Placebo Timing 3
    Participants in this arm will receive single oral dose of the Placebo.
  • Placebo Comparator: Placebo Timing 4
    Participants in this arm will receive single oral dose of the Placebo.

Primary Outcome Measure

Laboratory-Confirmed Infection [ Time Frame: From Day 1 (pm) up to Day 8 (am) ]

Central Contacts

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