Clinical Trial

Disease: E. coli infections (NCT05277350)

Disease info:

Most strains of E. coli are not harmful but are part of the healthful bacterial flora in the human gut. Ingestion of these strains causes infection with symptoms including, but not limited to, severe stomach cramps, diarrhoea, fever and vomiting. In some cases, the bacteria can translocate from the gut to the bloodstream causing sepsis. In cancer patients with haematological malignancies, which are cancers that affect the blood, bone marrow, and lymph nodes, these infections causing sepsis are especially severe. These patients are at increased risk of life-threatening bloodstream infections as a result of their disease and chemotherapy treatment, rendering the patients immunologically compromised.

 

 

Frequency:
Blood stream infections in cancer patiens could be caused by E. coli in >40% of the cases (Cornejo-Juárez, P., et al)
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: Tina M Ramey, +1.513.579.9911 (ext 12576), email: t.ramey1@medpace.com

Sponsor:
Partners:

Biomedical Advanced Research and Development Authority

Wellcome Trust

Locations:

Not yet disclosed

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: Active recruiting

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: Apr. 22, 2022
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