drugset / Trial / NCT06938867
Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant
Phase 1/2
Recruiting
24 enrolled
SNIPR Biome Aps.
Bill and Melinda Gates Foundation · collabBiomedical Advanced Research and Development Authority · collabDepartment of Health and Social Care, UK · collabGerman Federal Ministry of Education and Research · collabWellcome Trust · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2025-02-25
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | SNIPR001 | CRISPR / gene editing | — | Oral |