A phase 1b/2a, randomized, double-blind study to investigate safety, tolerability, PK, PD, and preliminary efficacy of oral administration of SNIPR001 in patients with hematologic malignancy scheduled for allogeneic hematopoietic stem-cell transplantation receiving fluoroquinolone prophylaxis and harboring fluoroquinolone-resistant Escherichia coli pre-transplant

Description

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. The study consists of two parts. Part 1 will include 24 randomized and dosed patients. Part 2 will be added with amendment 3 and will include 42 randomized and dosed patients. Thus, approximately 66 patients will be randomized 1:1 to oral dosing of SNIPR001 or matching placebo, to be taken concomitantly with SoC levofloxacin prophylaxis. Subjects will be followed until 100 days post allo-HSCT transplant.

Resources and Links

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT06938867 Opens a new window