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

• Sponsor: SNIPR Biome Aps. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05277350
• Collaborator: Biomedical Advanced Research and Development Authority (U.S. Fed), Wellcome Trust (Other)
• Enrollment: 36
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 11.6
• Patients Per Site Per Month: 3.1

Study Details

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
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Dose escalationDose 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: Mar 24, 2022
• Anticipated Primary Completion Date: Oct 12, 2022
• Anticipated Study Completion Date: Mar 13, 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. [35 days]

Secondary Outcome Measures

1. Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study [152 days]

2. Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations [187 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

• 1. 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

	Site	City	State	Country	Postal Code
1	Medpace Clinical Pharmacology	Cincinnati	Ohio	United States	45227

Sponsors and Collaborators

• SNIPR Biome Aps.
• Biomedical Advanced Research and Development Authority
• Wellcome Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SNIPR Biome Aps.
• ClinicalTrials.gov Identifier: NCT05277350
• Other Study ID Numbers: SNIPR001-001
• First Posted: Mar 14, 2022
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• 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

Study Results

No Results Posted as of Jul 22, 2022