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

NCT05182749 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: ITX/SA-001Shigella CVD 32000HP-00097063
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bacteriophage; phage; Shigella

Outcome Measures

Primary Outcomes (3)

• Phase 1: Number and Severity of Solicited and Unsolicited Adverse Reactions

  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

  Up to Day 90

• Phase 2a: Onset of Clinical Shigellosis Post-Challenge

  Clinical shigellosis with onset during Day 2 to Day 7 post-challenge, defined as fever, diarrhea, and/or dysentery

  Day 2 to Day 7 (Post-Challenge)

• Phase 2a: Number of Solicited and Unsolicited Adverse Reactions

  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

  Up to Day 90

Secondary Outcomes (3)

• Phase 2a: Onset of Moderate-to-Severe Shigellosis Post-Challenge

  Day 2 to Day 7 (Post-Challenge)

• Phase 2a: Severity of Shigellosis Symptoms

  Day 2 to Day 7 (Post-Challenge)

• Phase 2a: Number of Shigella Organisms Secreted in Stool

  Up to Day 15

Other Outcomes (5)

• Phase 1: Effect on Gut Microbiome Community States

  Up to Day 29

• Phase 1: Number of Shigella-specific Bacteriophage Shed in Stool

  Up to Day 29

• Phase 2a: Number of Shigella-specific Bacteriophage Shed in Stool

  Up to Day 15

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dose is 1mL of placebo given orally three times a day for 7 days (Phase 1) or 6 days (Phase 2a)

Other: Placebo

Bacteriophage

EXPERIMENTAL

Dose is 1mL of bacteriophage preparation given orally three times a day for 7 days (Phase 1) or 6 days (Phase 2a)

Biological: bacteriophage

Interventions

bacteriophage BIOLOGICAL

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

Also known as: ShigActive

Bacteriophage

Placebo OTHER

Placebo orally administered with sodium bicarbonate solution

Also known as: Phosphate Buffered Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 50 years.
• Access to CVD clinical site and available and willing to be followed for the planned duration of the study, including all follow-up visits.
• Able and willing to provide informed consent.
• Willing to participate after all aspects of trial explained.
• Assessment of understanding:
• Volunteer demonstrates understanding of this study;
• Completes a questionnaire prior to first treatment with verbal demonstration of understanding of all questionnaire items answered incorrectly;
• Receives a passing score of 70% or higher on the Comprehension Assessment Tool.
• Agrees not to enroll in another study of an investigational research agent during the study, with the exception of potentially life-saving or COVID-19-related experimental treatments.
• Good general health as shown by medical history, physical exam, and screening laboratory tests or clinical laboratory abnormalities per clinical judgment of the PI.
• Agrees not to donate blood or blood products during participation in the study or for 30 days after completion of study participation.
• Within normal/acceptable laboratory ranges during screening including:
• Absolute neutrophil count (1,500-8,000/mm\^3; 1,200-8,000/mm\^3 for African-American subjects);
• Bilirubin (\<1.4 mg/dL unless known Gilbert's syndrome, then \>2.0 mg/dL);
• Serum IgA (≥70 mg/dL or below lower limit of normal range);

You may not qualify if:

• Blood products received within 120 days before first treatment.
• Investigational research agents received within 30 days before first treatment.
• Body mass index (BMI) less than 19.0 kg/m2 or greater than 36.0 kg/m2.
• Pregnant or breastfeeding.
• Poor venous access, as defined by inability to obtain venous blood after 3 venipuncture attempts.
• Persons whose occupation involves the handling of ETEC, cholera, or Shigella bacteria.
• Regular (one time per week or more) use of antidiarrheals, stool softeners, laxatives, antacids, or other agents to lower stomach acidity.
• Use of oral or IV antimicrobials within 2 weeks of study start or planned use during active study phase.
• Proton pump inhibitors, H2 blockers or antacids within 48 hours prior to dosing or planned use during active study phase.
• Abnormal bowel patterns, defined by \<3 stools per week or \>2 stools per day on average over the past 6 months.
• Taking supplemental probiotics in the form of pills or tablets within 2 weeks of enrollment or during study period.
• Received prior vaccines, challenges or known exposure to (e.g., laboratory worker) Shigella within the past 3 years.
• Live attenuated vaccines received within 30 days before first study treatment or scheduled within 14 days after the first study treatment (e.g., measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine).
• Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first treatment (e.g., COVID-19, tetanus, pneumococcal, hepatitis A or B).
• Allergy treatment with antigen injections within 30 days before first treatment or that are scheduled within 14 days after first treatment.

Sponsors & Collaborators

• Intralytix, Inc.: lead
• University of Maryland, Baltimore: collaborator

Study Sites (1)

University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Alexander Sulakvelidze, PhD

  Intralytix, Inc.

  STUDY DIRECTOR

• Wilbur Chen Chen, MD, MS

  University of Maryland, Baltimore, Center for Vaccine Development and Global Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 10, 2022
• Study Start: February 23, 2023
• Primary Completion: December 9, 2024
• Study Completion: September 30, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)