drugset / Trial / NCT02380924

Recovery and Survival of EryDex in Non-patient Volunteers

NCT02380924 ↗

Phase 1 Completed 10 enrolled Quince Therapeutics S.p.A.
RandomizedParallel-groupSingle-blindTreatment

Summary

This is a randomized, single-blind, single-center, concurrently controlled, exploratory, Phase I study to determine the in vivo kinetics (24-hour post-infusion recovery and T50 survival) of EryDex System (EDS) -processed autologous red blood cells (RBC) in non-patient volunteers. A total of 12 non-patient volunteer subjects will be enrolled and assigned to one of the 2 groups (6 subjects in active arm group, 6 subjects in sham arm group).

Timeline

Start
2015-01
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 10 mg Intravenous

Indications

No indication recorded.