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

• ClinicalTrials.gov Identifier: NCT05277350
• Recruitment Status: Completed
• First Posted: March 14, 2022
• Last Update Posted: May 17, 2023
• Sponsor: SNIPR Biome Aps.
• Collaborators: Biomedical Advanced Research and Development Authority; Wellcome Trust
• Information provided by (Responsible Party): SNIPR Biome Aps.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
E.Coli Infections; Bloodstream Infection	Drug: SNIPR001; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Dose escalation
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: double-blind
• Primary Purpose: Other
• 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
• Actual Study Start Date: March 24, 2022
• Actual Primary Completion Date: November 30, 2022
• Actual Study Completion Date: May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 35 days ]

Secondary Outcome Measures :

1. Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study [ Time Frame: 152 days ]
2. Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations [ Time Frame: 187 days ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Medpace Clinical Pharmacology

Cincinnati, Ohio, United States, 45227

Sponsors and Collaborators

SNIPR Biome Aps.

Biomedical Advanced Research and Development Authority

Wellcome Trust

More Information

• Responsible Party: SNIPR Biome Aps.
• ClinicalTrials.gov Identifier: NCT05277350
• Other Study ID Numbers: SNIPR001-001
• First Posted: March 14, 2022
• Last Update Posted: May 17, 2023
• Last Verified: May 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; Communicable Diseases; Sepsis; Escherichia coli Infections; Disease Attributes; Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses