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

NCT05277350 | Completed Phase 1 FDA Drug

• 1 other identifier: SNIPR001-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

E.Coli Infections; Bloodstream Infection

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

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

Drug: SNIPR001; Drug: Placebo

Cohort 2

ACTIVE COMPARATOR

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

Drug: SNIPR001; Drug: Placebo

Cohort 3

ACTIVE COMPARATOR

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

Drug: SNIPR001; Drug: Placebo

Interventions

SNIPR001 DRUG

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

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

Matching placebo

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: March 24, 2022
• Primary Completion: November 30, 2022
• Study Completion: May 1, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

US (1)