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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05277350
Recruitment Status : Completed
First Posted : March 14, 2022
Last Update Posted : May 17, 2023
Sponsor:
Collaborators:
Biomedical Advanced Research and Development Authority
Wellcome Trust
Information provided by (Responsible Party):
SNIPR Biome Aps.

Tracking Information
First Submitted Date  ICMJE March 3, 2022
First Posted Date  ICMJE March 14, 2022
Last Update Posted Date May 17, 2023
Actual Study Start Date  ICMJE March 24, 2022
Actual Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2022)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2022)
  • Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study [ Time Frame: 152 days ]
  • Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations [ Time Frame: 187 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2022)
  • Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study [ Time Frame: 152 days ]
  • Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations [ Time Frame: 35 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Dose escalation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose: Other
Condition  ICMJE
  • E.Coli Infections
  • Bloodstream Infection
Intervention  ICMJE
  • Drug: SNIPR001
    SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli
  • Drug: Placebo
    Matching placebo
Study Arms  ICMJE
  • Active Comparator: Cohort 1
    6 participants on SNIPR001 (Dose 1 BID for 7 days) and 2 participants on placebo
    Interventions:
    • Drug: SNIPR001
    • Drug: Placebo
  • Active Comparator: Cohort 2
    6 participants on SNIPR001 (Dose 2 BID for 7 days) and 2 participants on placebo
    Interventions:
    • Drug: SNIPR001
    • Drug: Placebo
  • Active Comparator: Cohort 3
    12 participants on SNIPR001 (Dose 3 BID for 7 days) and 8 participants on placebo
    Interventions:
    • Drug: SNIPR001
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2022)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2023
Actual Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05277350
Other Study ID Numbers  ICMJE SNIPR001-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party SNIPR Biome Aps.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE SNIPR Biome Aps.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Biomedical Advanced Research and Development Authority
  • Wellcome Trust
Investigators  ICMJE Not Provided
PRS Account SNIPR Biome Aps.
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP