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

• Status: Not yet recruiting
• Trial end date: 2023-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SNIPR Biome Aps.
• Collaborators: Biomedical Advanced Research and Development Authority; Wellcome Trust

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

• Fever (≥ 38°C)

• 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