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.
Male or female ≥18 years of age at the time of consent.
Patient is able and willing to provide written informed consent prior to any study-related procedure.
Confirmed diagnosis of any hematologic malignancy.
Planned to undergo an allogeneic hematopoietic stem cell transplant.
Use of any treatment (approved or investigational product) considered to interact with the study drug, or which might impact the outcome of the study within 14 days (or 5 half-lives of the approved or investigational product, whichever is greater) prior to the first administration of study drug, as judged by the Investigator.
Use or planned use of any antibiotics with intrinsic activity against E. coli in the gut (e.g., beta-lactam antibiotics) between Pre-Screening and until the end of the SNIPR001/placebo treatment period, with the exception of TMP-SMX and levofloxacin.
Have known hypersensitivity or allergy to any component of SNIPR001, levofloxacin and/or Alka-Seltzer Gold treatment.
Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples.
SNIPR Biome Aps.
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
Department of Health and Social Care, UK
Collaborator
Biomedical Advanced Research and Development Authority
Collaborator
Wellcome Trust
Collaborator
German Federal Ministry of Education and Research
Collaborator