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

Primary Purpose

E.Coli Infections, Bloodstream Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SNIPR001

Placebo

About this trial

This is an interventional other trial for E.Coli Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Medpace Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

6 participants on SNIPR001 (Dose 1 BID for 7 days) and 2 participants on placebo

6 participants on SNIPR001 (Dose 2 BID for 7 days) and 2 participants on placebo

12 participants on SNIPR001 (Dose 3 BID for 7 days) and 8 participants on placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study

Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations

Full Information

NCT ID

NCT05277350

First Posted

March 3, 2022

Last Updated

May 16, 2023

Sponsor

SNIPR Biome Aps.

Collaborators

Biomedical Advanced Research and Development Authority, Wellcome Trust

1. Study Identification

Unique Protocol Identification Number

NCT05277350

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

March 24, 2022 (Actual)

Primary Completion Date

November 30, 2022 (Actual)

Study Completion Date

May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SNIPR Biome Aps.

Collaborators

Biomedical Advanced Research and Development Authority, Wellcome Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

E.Coli Infections, Bloodstream Infection

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Dose escalation

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double-blind

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Active Comparator

Arm Description

6 participants on SNIPR001 (Dose 1 BID for 7 days) and 2 participants on placebo

Arm Title

Cohort 2

Arm Type

Active Comparator

Arm Description

6 participants on SNIPR001 (Dose 2 BID for 7 days) and 2 participants on placebo

Arm Title

Cohort 3

Arm Type

Active Comparator

Arm Description

12 participants on SNIPR001 (Dose 3 BID for 7 days) and 8 participants on placebo

Intervention Type

Drug

Intervention Name(s)

SNIPR001

Intervention Description

SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study

Time Frame

152 days

Title

Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations

Time Frame

187 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Medpace Clinical Pharmacology

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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