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

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

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.

Study Overview

• Status: Completed
• Conditions: Bloodstream Infection; E.Coli Infections
• Intervention / Treatment: Drug: Placebo; Drug: SNIPR001

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: SNIPR Biome Aps.
• Collaborators: Wellcome Trust; Biomedical Advanced Research and Development Authority

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Sepsis; Infections; Communicable Diseases; Escherichia coli Infections
• Other Study ID Numbers: SNIPR001-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No