Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05182749 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Dec 21, 2024 to Dec 9, 2024
    • Study completion date: Jun 30, 2025 to Sep 30, 2025
    v9
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 23, 2025 to Dec 21, 2024
    • Site details revised
    v8
  3. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v7
  4. Trial status: Recruiting to Active, Not Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Apr 30, 2025 to Jun 23, 2025
    • Study completion date: Apr 30, 2025 to Jun 30, 2025
    • Start date changed from estimate of Feb 14, 2023 to Feb 23, 2023
    • Site details revised
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 31, 2023 to Feb 14, 2023
    • Site details revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Sep 1, 2022 to Jan 31, 2023v4
  2. Start date: May 1, 2022 to Sep 1, 2022v3
  3. Secondary endpoints: details revised at 2 of 3 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge.
Trial Details
NCT Number NCT05182749
Lead Sponsor Intralytix, Inc.
Collaborators: University of Maryland, Baltimore
Conditions
(from sponsor)		 Shigellosis
Related terms Dysentery, Bacillary
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov