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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: Active Phase 1 study of Shigellosis, sponsored by Intralytix.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of subjects reporting solicited and unsolicited AEs, laboratory measures of safety, and adverse (up to Day 29) and serious adverse events (up to Day 90) following treatment with ShigActive or placebo
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 |
What the registry record for NCT05182749 still lists
NCT05182749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 72-participant average among 3 other Shigellosis trials with a reported enrollment target (28% lower).
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 a single indexed study location in 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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