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

NCT05182749 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-06-15

No results posted yet for this 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

  • Shigellosis

Interventions

BIOLOGICAL

bacteriophage

A cocktail of lytic Shigella-specific bacteriophages orally administered with sodium bicarbonate solution

OTHER

Placebo

Placebo orally administered with sodium bicarbonate solution

Sponsors & Collaborators

  • University of Maryland, Baltimore

    collaborator OTHER

  • Intralytix, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexander Sulakvelidze, PhD · Intralytix, Inc.

  • Wilbur Chen Chen, MD, MS · University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-23
Primary Completion
2024-12-09
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05182749 on ClinicalTrials.gov