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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
| Wellcome Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | 6 participants on SNIPR001 (Dose 1 BID for 7 days) and 2 participants on placebo |
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| Cohort 2 | Active Comparator | 6 participants on SNIPR001 (Dose 2 BID for 7 days) and 2 participants on placebo |
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| Cohort 3 | Active Comparator | 12 participants on SNIPR001 (Dose 3 BID for 7 days) and 8 participants on placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNIPR001 | Drug | SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace Clinical Pharmacology | Cincinnati | Ohio | 45227 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41785880 | Derived | 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. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Dose escalation
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double-blind
| Placebo | Drug | Matching placebo |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |