Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Prelimi
This is a Phase 1b/2a study in allogenic hematopoietic stem cell transplant patients to investigate the safety, PK, PD and preliminary efficacy of multiple oral administrations of SNIPR001 when given concomitantly with SoC levofloxacin.
| Condition(s) | E Coli Infections, Allogenic Transplant Patients |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is a Phase 1b/2a study in allogenic hematopoietic stem cell transplant patients to investigate the safety, PK, PD and preliminary efficacy of multiple oral administrations of SNIPR001 when given concomitantly with SoC levofloxacin. |
| Who can participate | Inclusion Criteria: 1. Male or female ≥18 years of age at the time of consent. 2. Patient is able and willing to provide written informed consent prior to any study-related procedure. 3. Confirmed diagnosis of any hematologic malignancy. 4. Planned to undergo an allogeneic hematopoietic stem cell transplant. 5. Patient is scheduled to receive fluoroquinolone (levofloxacin) prophylaxis. 6. Colonized with Fluoroquinolone resistant E. coli (patients will be pre-screened for the presence of at least 1 Fluoroquinolone resistant E. coli colony \[cultured from a perianal swab\] performed at the local hospital lab, qualitative assessment +/-). 7. Female patients must be of non-childbearing potential (surgically sterile or menopausal for at least 1 year) or agree to use a highly effective contracep |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | SNIPR Biome Aps. |
| Locations | Duarte, California, United States; San Francisco, California, United States; Baltimore, Maryland, United States; Minneapolis, Minnesota, United States; New York, New York, United States; Pittsburgh, Pennsylvania, United States (+2 more sites) |
| Start date | 2025-02-25 |
| NCT ID | NCT06938867 |
| Official listing | https://clinicaltrials.gov/study/NCT06938867 |