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

Bloodstream Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05277350
• Other study ID #: SNIPR001-001
• Status: Completed
• Phase: Phase 1
• Start date: March 24, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: SNIPR Biome Aps.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 1, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bloodstream Infection
• Communicable Diseases
• E.Coli Infections
• Escherichia coli Infections
• Infections
• Sepsis

Intervention

Drug:
• SNIPR001
SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Medpace Clinical Pharmacology	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
SNIPR Biome Aps.	Biomedical Advanced Research and Development Authority, Wellcome Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study		152 days
Secondary	Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations		187 days