A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
NCT ID: NCT05277350
Last Updated: 2023-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2022-03-24
2023-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
QUADRUPLE
Study Groups
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Cohort 1
6 participants on SNIPR001 (Dose 1 BID for 7 days) and 2 participants on placebo
SNIPR001
SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli
Placebo
Matching placebo
Cohort 2
6 participants on SNIPR001 (Dose 2 BID for 7 days) and 2 participants on placebo
SNIPR001
SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli
Placebo
Matching placebo
Cohort 3
12 participants on SNIPR001 (Dose 3 BID for 7 days) and 8 participants on placebo
SNIPR001
SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli
Placebo
Matching placebo
Interventions
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SNIPR001
SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Wellcome Trust
OTHER
SNIPR Biome Aps.
INDUSTRY
Responsible Party
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Locations
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Medpace Clinical Pharmacology
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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SNIPR001-001
Identifier Type: -
Identifier Source: org_study_id
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