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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

NCT06938867 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-10-14

No results posted yet for this study

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.

Conditions

  • E Coli Infections
  • Allogenic Transplant Patients

Interventions

BIOLOGICAL

SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli

SNIPR001 is a live biotherapeutic product

OTHER

Placebo 10 mL

Placebo 10 mL matching to SNIPR001 will be administered.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Department of Health and Social Care (DHSC), UK

    collaborator UNKNOWN

  • Biomedical Advanced Research and Development Authority

    collaborator FED

  • Wellcome Trust

    collaborator OTHER

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • SNIPR Biome Aps.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2026-04-01
Completion
2026-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06938867 on ClinicalTrials.gov