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ShigellosisPhase 1/2NCT05182749

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

A Phase 1/2 study testing bacteriophage in people with Shigellosis, run by Intralytix, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Shigellosis
What is being tested?
bacteriophage
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteUnited States
Study dates
23 Feb 2023to 30 Sep 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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);
  • HLA-B27 negative (Phase 2a only);
  • Stool culture (No Salmonella, Shigella, Campylobacter, Yersinia; presence of normal flora; no pathogenic protozoa by microscopic examination).
  • Hemoglobin ≥11.5 g/dL for volunteers who were assigned female sex at birth, ≥13.0 g/dL for volunteers who were assigned male sex at birth.
  • For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (i.e., a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth).
  • White blood cell count = 3,300 to 11,000 (2,800-11,000 for African-Americans) cells/mm^3.
  • Total lymphocyte count ≥800 cells/mm^3.
  • Remaining differential either within institutional normal range or with site physician approval.
  • Platelets = 125,000 to 450,000/mm^3.
  • Chemistry panel: alanine aminotransferase (ALT) <1.25 times the institutional upper limit of normal and creatinine ≤ institutional upper limits of normal.
  • Negative HIV-1 and -2 blood test: must have a negative FDA-approved enzyme immunoassay (EIA).
  • Negative for HBsAg.
  • Negative for HCV antibody.
  • Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to enrollment and within 24 hours of initial treatment.
  • Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy are not required to undergo pregnancy testing.
  • Reproductive status: A volunteer who was assigned female sex at birth must agree to use adequate contraception, defined as consistent and correct use of an FDA-recommended contraceptive method or combination of methods in accordance with the product label. For example:
  • Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide, and another method such as prescription hormonal contraceptive;
  • Intrauterine device (IUD);
  • Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch) subdermal, or intramuscular route used in combination with another method, such as barrier methods;
  • Total abstinence;
  • Sterilization of a female participant's monogamous male partner prior to entry into the study;
  • Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation.
  • Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit.
  • Phase 2a only: Available for a 12-day inpatient stay.
  • Phase 2a only: Fully vaccinated against COVID-19 for at least 30 days prior to enrollment.
  • Phase 2a only: Successful completion of inpatient acclimation period on Day -1.

Who cannot join

  • 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.
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  • 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.
  • Immunosuppression as the result of an underlying illness
  • Immunosuppressive medications received within 30 days before first treatment or planned use during study (Not exclusionary: 1) corticosteroid nasal spray; 2) inhaled corticosteroids; 3) topical corticosteroids for mild, uncomplicated dermatitis; or 4) a single course of oral/parenteral prednisone or equivalent at doses <60 mg/day and length of therapy <11 days with completion at least 30 days prior to enrollment).
  • Immunoglobulin received within 60 days before first treatment.
  • Autoimmune disease (Not exclusionary: mild, well-controlled psoriasis).
  • History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up.)
  • Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
  • A process that would affect the immune response;
  • A process that would require medication that affects the immune response;
  • Any contraindication to repeated injections or blood draws;
  • A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period;
  • A condition or process for which signs or symptoms could be confused with reactions to treatment or challenge;
  • Any condition specifically listed among the exclusion criteria below:
  • Chronic liver disease, renal insufficiency, unstable or progressive neurological disorders, diabetes mellitus, collagen vascular disease (such as lupus), active neoplastic disease (not cured or in remission), previous hematological malignancy, or seizure since the age of 21 years;
  • Any of the following in the past 10 years: Crohn's disease, ulcerative colitis, irritable bowel disease, celiac disease, stomach or intestinal ulcers, or 2 or more episodes of inflammatory arthritis (joint pain and swelling);
  • Any history of recurrent infections;
  • Any current illness requiring daily medication (vitamins, birth control pills, nasal or topical medications, allowed);
  • Blood in stool on >2 occasions (other than small amounts from straining) in past 12 months;
  • Recurrent diarrhea (>5 episodes in past 6 months, each lasting >3 days or more).
  • History of excessive alcohol consumption or drug dependence within last 3 years
  • Any medical, psychiatric, occupational, or other condition that, in the judgment of the Investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent
  • Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions.)
  • Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the Investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study.)
  • Seizure disorder/epilepsy: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years
  • Asplenia: any condition resulting in the absence of a functional spleen
  • History of chronic GI illness, including severe dyspepsia, lactose intolerance, or other significant GI tract disease (e.g., irritable bowel syndrome, inflammatory bowel syndrome, gastric ulcer disease)
  • Any other criteria which, in the Investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study, or the results of the study
  • Phase 2a only: Occupation as a food handler, in child-care, in elder-care or as a healthcare worker with direct contact from challenge to 4 weeks after discharge home.
  • Phase 2a only: Serum Shigella flexneri 2a LPS IgG titer of ≥2500
  • Phase 2a only: History of diarrhea in the 7 days prior to treatment (outpatient diarrhea is defined as ≥ 3 unformed [Grade 3 or greater] loose stools in 24 hours).
  • Phase 2a only: Screening stool culture positive for the presence of Salmonella, Shigella, Campylobacter, Yersinia, Vibrio cholera or presence of pathogenic protozoa by microscopic examination.
  • Phase 2a only: Screening stool culture with an absence of normal flora.
  • Phase 2a only: Subjects who are unwilling to abstain from taking antipyretics or analgesics during the 7 days following treatment.
  • Phase 2a only: Persons with IgA deficiency (serum IgA <70 mg/dL)
  • Phase 2a only: Symptoms of traveler's diarrhea associated with travel to countries where Shigella or other enteric infections are endemic (most of the developing world) within 3 years prior to dosing
  • Phase 2a only: History of shigellosis within the last 3 years
  • Phase 2a only: History of the following types of abdominal surgery:
  • Any major GI surgery (e.g., intestinal resection or splenectomy);
  • Laparoscopic abdominal surgery within the past year;
  • Presence of a large abdominal scar of unclear origin.
  • Phase 2a only: Known significant allergy to ciprofloxacin or trimethoprim-sulfamethoxazole.
  • Phase 2a only: Electrocardiogram (ECG) with clinically significant findings or features that would interfere with the assessment of myo/pericarditis, as determined by a contract ECG Lab or cardiologist, including any of the following:
  • Conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS ≥120 ms, PR interval ≥220 ms, any second or third degree AV block, or QTc prolongation >450 ms);
  • Repolarization (ST segment or T wave) abnormality that will interfere with the assessment of myo/pericarditis;
  • Significant atrial or ventricular arrhythmia;
  • Frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, 2 premature ventricular contractions in a row);
  • ST elevation consistent with ischemia;
  • Evidence of past or evolving myocardial infarction.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis With Shigella Flexneri 2a Strain

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.

Read the detailed description

The purpose of this study is to determine if ShigActive is safe and effective in healthy adults in a continuous Phase 1/2a trial. Phase 1 will asses the safety of ShigActive in healthy adults, while Phase 2a will evaluate the safety and efficacy of ShigActive in healthy adults after a challenge with Shigella.

ShigActive is a collection of bacteriophages. Bacteriophages (or phages) are viruses that infect only bacteria. The phages in ShigActive infect a specific type of bacteria called Shigella, which is the causative agent of shigellosis or dysentery. ShigActive is intended to significantly reduce or eliminate Shigella levels in the human gastrointestinal tract, which in turn, is anticipated to reduce the incidence and/or severity of shigellosis.

Conditions
Shigellosis
Being tested
bacteriophage, Placebo
Keywords
bacteriophage, phage, Shigella
Medical subject headings
Dysentery, Bacillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bacteriophageBiological

    Also called ShigActive

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

  • PlaceboOther

    Also called Phosphate Buffered Saline

    Placebo orally administered with sodium bicarbonate solution

Study groups in NCT05182749
Study groupRoleWhat they receive
PlaceboPlacebo comparatorDose is 1mL of placebo given orally three times a day for 7 days (Phase 1) or 6 days (Phase 2a)
Receives: Other: Placebo
BacteriophageExperimentalDose is 1mL of bacteriophage preparation given orally three times a day for 7 days (Phase 1) or 6 days (Phase 2a)
Receives: Biological: bacteriophage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to Day 90

  2. 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

    Measured: Day 2 to Day 7 (Post-Challenge)

  3. 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

    Measured: Up to Day 90

Secondary outcomes (3)

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

    Moderate-to-severe shigellosis with onset during Day 2 to Day 7 post-challenge, defined using graded disease severity scoring methods (Grade 3 [mild] to Grade 5 [severe]) defined by number of loose stools, fever, dysentery, and abdominal cramping

    Measured: Day 2 to Day 7 (Post-Challenge)

  2. Phase 2a: Severity of Shigellosis Symptoms

    Severity of shigellosis symptoms (e.g., diarrhea, dysentery, fever) using graded severity scoring methods (Grade 1 [mild] to Grade 3 [severe])

    Measured: Day 2 to Day 7 (Post-Challenge)

  3. Phase 2a: Number of Shigella Organisms Secreted in Stool

    Qualitative and quantitative (mean, median and geometric mean colony forming units [CFUs]) assessment of Shigella challenge strain shedding in stool samples following treatment with ShigActive or placebo, and challenge with Shigella

    Measured: Up to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start23 Feb 2023
  3. Primary completion9 Dec 2024
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182749
Sponsor's protocol ID
ITX/SA-001
Other IDs
Shigella CVD 32000, HP-00097063
Status last verified
Jun 2025
First submitted
21 Dec 2021
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bacteriophage in people with Shigellosis, run by Intralytix, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 62 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number and Severity of Solicited and Unsolicited Adverse Reactions (time frame: Up to Day 90). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05182749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

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