ShigActive / Intralytix - LARVOL DELTA

Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis (clinicaltrials.gov) - P1/2 | N=52 | Active, not recruiting | Sponsor: Intralytix, Inc. | Trial completion date: Jun 2025 ➔ Sep 2025

Trial completion date

Safety and Tolerability of ShigActive™, a Shigella spp. Targeting Bacteriophage Preparation, in a Phase 1 Randomized, Double-Blind, Controlled Clinical Trial. (PubMed, Antibiotics (Basel)) - "Additionally, no significant differences in GI-associated inflammatory mediators or fecal microbiome changes were observed between placebo- and ShigActive™-treated subjects, or from a participants' baseline value. The results of this first-in-human (FIH) randomized, controlled Phase 1 trial of ShigActive™ demonstrate that it is safe and well tolerated when orally administered with no significant differences compared to placebo controls."

Clinical • Journal • P1 data • Fatigue • Gastrointestinal Disorder • Infectious Disease

Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis (clinicaltrials.gov) - P1/2 | N=52 | Active, not recruiting | Sponsor: Intralytix, Inc. | Trial primary completion date: Jun 2025 ➔ Dec 2024 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date