E.Coli InfectionsPhase 1NCT05277350
A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
A Phase 1 study testing SNIPR001 in people with E.Coli Infections and Bloodstream Infection, run by SNIPR Biome Aps. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- E.Coli Infections, Bloodstream Infection
- What is being tested?
- SNIPR001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2022to 1 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227
About this study
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
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.
Read the 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.
- Conditions
- E.Coli Infections, Bloodstream Infection
- Being tested
- SNIPR001, Placebo
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNIPR001Drug
SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | 6 participants on SNIPR001 (Dose 1 BID for 7 days) and 2 participants on placebo Receives: Drug: SNIPR001; Drug: Placebo |
| Cohort 2 | Active comparator | 6 participants on SNIPR001 (Dose 2 BID for 7 days) and 2 participants on placebo Receives: Drug: SNIPR001; Drug: Placebo |
| Cohort 3 | Active comparator | 12 participants on SNIPR001 (Dose 3 BID for 7 days) and 8 participants on placebo Receives: Drug: SNIPR001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 35 days
Secondary outcomes (2)
Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study
Measured: 152 days
Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations
Measured: 187 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start24 Mar 2022
- Primary completion30 Nov 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for E.Coli InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SNIPR Biome Aps.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, Wellcome Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277350
- Sponsor's protocol ID
- SNIPR001-001
- Status last verified
- May 2023
- First submitted
- 3 Mar 2022
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Petersen AO, Damholt B, Grove M, Hink J, Marotte-Hurbon T, Soderqvist J, Troy A, Zdravkovic M, Bayer L, Brunner K, Bryde T, Clube J, Gencay YE, Gram A, Haaber JK, Hallstrom B, Jasinskyte D, Pascal R, Petersen M, Semsey S, Torio AS, Turcu IC, Smrekar F, Taur Y, Satlin MJ, Sommer MOA, van der Helm E, Grondahl C. Safety, recovery, and pharmacodynamics of CRISPR-Cas therapeutic SNIPR001: a phase 1, randomised, double-blind, first-in-human, dose-escalation study. Lancet Microbe. 2026 Apr;7(4):101257. doi: 10.1016/j.lanmic.2025.101257. Epub 2026 Mar 2.
PubMed 41785880
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05277350
- Acronym / sponsor ID
- SNIPR001-001
- Conditions
- E.Coli Infections, Bloodstream Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SNIPR Biome Aps.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, Wellcome Trust
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Dose escalation
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: SNIPR001, Drug: Placebo6 participants on SNIPR001 (Dose 1 BID for 7 days) and 2 participants on placebo |
| Cohort 2 | Active comparator | Drug: SNIPR001, Drug: Placebo6 participants on SNIPR001 (Dose 2 BID for 7 days) and 2 participants on placebo |
| Cohort 3 | Active comparator | Drug: SNIPR001, Drug: Placebo12 participants on SNIPR001 (Dose 3 BID for 7 days) and 8 participants on placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNIPR001SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboMatching placebo | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 41785880Petersen AO, Damholt B, Grove M, Hink J, Marotte-Hurbon T, Soderqvist J, Troy A, Zdravkovic M, Bayer L, Brunner K, Bryde T, Clube J, Gencay YE, Gram A, Haaber JK, Hallstrom B, Jasinskyte D, Pascal R, Petersen M, Semsey S, Torio AS, Turcu IC, Smrekar F, Taur Y, Satlin MJ, Sommer MOA, van der Helm E, Grondahl C. Safety, recovery, and pharmacodynamics of CRISPR-Cas therapeutic SNIPR001: a phase 1, randomised, double-blind, first-in-human, dose-escalation study. Lancet Microbe. 2026 Apr;7(4):101257. doi: 10.1016/j.lanmic.2025.101257. Epub 2026 Mar 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNIPR001 in people with E.Coli Infections and Bloodstream Infection, run by SNIPR Biome Aps. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.