Clinical Trial

Disease: E. coli infections, (NCT05277350)

Disease info:

Escherichea coli (E. coli) infections are caused by a type of bacteria that normally resides in the intestines, with most strains being harmless. However, certain strains can cause infection and illness such as diarrhea, urinary tract infections, pneumonia, sepsis, and other illnesses. 

The most common E. coli infection results in diarrhea, including severe forms like bloody diarrhea, which may result in kidney failure or death, especially in vulnerable individuals. Shiga toxin-producing E. coli (STEC) infection can cause a severe condition known as hemolytic uremic syndrome (HUS), which may result in kidney failure, long-term health complications, or even death.

Infections cause nausea, vomiting, severe abdominal cramps, watery or bloody diarrhea, fatigue, and fever. Vulnerable groups like children and immunocompromised individuals are more prone to severe complications.

Frequency:
E. coli infections are very common, particularly in cases of foodborne illnesses or contaminated water exposure, with higher risks during outbreaks or in regions with poor sanitation.
Official title:
A Phase 1, Randomized, Double-Blind, First-In-Human, Dose Escalation Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
Who:

Contact

Name: Tina M Ramey

Phone: +15135799911 (ext 12576)

Email: t.ramey1@medpace.com

Sponsor:
Partners:

Biomedical Advanced Research and Development Authority

Wellcome Trust

Locations:

United States, Ohio

Medpace Clinical Pharmacology, Cincinnati, Ohio, United States, 45227

Study start:
Mar. 24, 2022
Enrollment:
36
Gene editing method:
CRISPR-Cas
Type of edit:
Gene knock-out
Gene:
Undisclosed
Delivery method:
Bacteriophage - In-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Completed

Description

This is a Phase 1, randomised, double-blind, placebo-controlled, multiple dose, dose escalation study in healthy participants, investigating the safety, tolerability, recovery, and pharmacodynamics of multiple oral administrations of SNIPR001. Approximately 36 healthy male and female participants will be randomised to one of 3 active oral doses of SNIPR001 or matching placebo, which will be administered twice a day (BID) for 7 days. Subjects will be followed up until 6 months after receiving the last dose of SNIPR001.

Last updated: Jan. 9, 2025
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