drugset / Trial / NCT03797040

Open-label Phase I Study for PEP or Treatment of HS-ARS PLX-R18 for the Post-Exposure Prevention (PEP) or Treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS)

NCT03797040 ↗

Phase 1 Unknown 27 enrolled Pluristem Ltd.
SequentialOpen-labelTreatment

Summary

The objective of the study is to evaluate the safety of intramuscular (IM) administration of PLX-R18 in subjects exposed to ionizing radiation and who are at risk of developing HS-ARS. Indication:Post-Exposure Prevention (PEP) or treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS) in subjects suspected to have been exposed to ionizing radiation.

Timeline

Start
2021-01
Primary completion
2021-12
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Subject PDA001 Cell therapy 4e+06 cells/kg Intramuscular