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

Study Overview
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Brief Summary
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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.

Detailed Description
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Approximately 36 healthy male and female participants will be randomized to one of 3 active oral doses of SNIPR001 or matching placebo, administered twice a day (BID) for 7 days. Subjects will be followed up until 6 months after receiving the last dose of SNIPR001.

Official Title
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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

Conditions
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E.Coli Infections, Bloodstream Infection

Intervention / Treatment
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* Drug: SNIPR001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Dose escalation
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1<br>6 participants on SNIPR001 (Dose 1 BID for 7 days) and 2 participants on placebo | Drug: SNIPR001<br>* SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli<br>Drug: Placebo<br>* Matching placebo<br>|
| Active Comparator: Cohort 2<br>6 participants on SNIPR001 (Dose 2 BID for 7 days) and 2 participants on placebo | Drug: SNIPR001<br>* SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli<br>Drug: Placebo<br>* Matching placebo<br>|
| Active Comparator: Cohort 3<br>12 participants on SNIPR001 (Dose 3 BID for 7 days) and 8 participants on placebo | Drug: SNIPR001<br>* SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli<br>Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by incidence and severity of AEs and Medically Attended Adverse Events (MAAEs) from the first administration of study drug and up until Day 35 of the study. |  | 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study |  | 152 days | 
| Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations |  | 187 days |