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NCT05182749 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
A Phase 1 study of Shigellosis, sponsored by Intralytix.
- Active
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT05182749 is a Phase 1 study of Shigellosis that is active but no longer recruiting, run by Intralytix. The registered enrollment target is 52 participants, below the 72-participant average among 3 other Shigellosis trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05182749, a Phase 1 study of Shigellosis, is active but no longer recruiting, sponsored by Intralytix.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL bacteriophage
Study Locations (1)
Maryland
- University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2023-02-23 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05182749
The ClinicalTrials.gov registry entry for NCT05182749 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 72-participant average among 3 other Shigellosis trials with a reported enrollment target (28% lower). The listed sponsor is Intralytix, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Shigellosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05182749 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05182749 about?
NCT05182749 is a clinical study titled "Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis". 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.
What is the current status of trial NCT05182749?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2023-02-23. Estimated completion is 2025-09-30.
What conditions does trial NCT05182749 study?
This clinical trial studies the following conditions: Shigellosis.
What interventions are being tested in trial NCT05182749?
The interventions under investigation include: Placebo (OTHER), bacteriophage (BIOLOGICAL).
Who is sponsoring clinical trial NCT05182749?
This trial is sponsored by Intralytix, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05182749 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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