A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: E.Coli Infections, Bloodstream Infection

In brief

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose, dose escalation study in healthy participants, investigating the safety, tolerability, recovery, and PD of multiple oral administrations of SNIPR001.

Key facts

Study ID: NCT05277350
Run by: SNIPR Biome Aps.
People needed: 36
Starts: 2022-03-24
Expected to finish: 2023-05-01
Last updated by the study team: 2023-05-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Signed informed consent
Male or female healthy subject defined as no known clinically relevant organ abnormality, or disease diagnosis, as per Investigator discretion
No clinically significant abnormalities indicated by safety laboratory test results
Age between 18 years and 65 years
E. coli present in feces sample
Normal defecation pattern (at least once daily)
Willing to participate in the study and provide fecal samples

You may not qualify if…

Treatment with antibiotics or any other prescription medication within the last 30 days prior to or during screening
Use of probiotics (not including dairy products) within the last 30 days prior to or during screening
Smoking (cigarettes, pipes, vaping products, etc.) within the last 3 months prior to or during screening
6 months prior to or during screening, recent history of alcohol or drug abuse, or current regular alcohol consumption of more than 14 units per week (one unit of alcohol equals one beer (285 ml), one glass of wine (125 ml), or one glass of spirits (25 ml))
Positive alcohol or drugs of abuse test
Pregnancy or lactating or intention of becoming pregnant (all females to agree to use highly effective contraception (defined as those, alone or in combination, that result in a low failure rate i.e., less than 1% per year) for the entire study duration
Obesity as defined by WHO i.e., BMI>32 kg/m2
Known to be HIV-positive
Known active hepatitis B and/or hepatitis C infection
Known congenital or acquired immunodeficiency
Allergy to any component of the trial drug and ant-acid treatment
Regular use of medications that affect gastrointestinal motility e.g., antidiarrheals, stool softeners and laxatives, GLP-1 analogues

Where it is running

Medpace Clinical Pharmacology — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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