drugset / Trial / NCT05182749
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
Phase 1/2
Active not recruiting
52 enrolled
Intralytix, Inc.
University of Maryland, Baltimore · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2023-02-23
- Primary completion
- 2024-12-09
- Completion
- 2025-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bacteriophage | Other / unclassified | 1 ml | Oral |