Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model … (NCT05182749) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety and Efficacy of the Bacteriophage Preparation, ShigActiveâ„¢, in a Human Experimental Model of Shigellosis
United States52 participantsStarted 2023-02-23
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Phase 1: Number and Severity of Solicited and Unsolicited Adverse Reactions
Timeframe: Up to Day 90
2
Phase 2a: Onset of Clinical Shigellosis Post-Challenge
Timeframe: Day 2 to Day 7 (Post-Challenge)
3
Phase 2a: Number of Solicited and Unsolicited Adverse Reactions