drugset / Trial / NCT01589666

Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers

NCT01589666 ↗

Phase 1 Completed 27 enrolled Entegrion, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This study is a Phase 1, single-center, open-label, ascending dose study which will assess the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma (Resusix®) in healthy volunteers.

Timeline

Start
2013-11
Primary completion
2016-09-09
Completion
2016-09-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Spray-dried S/D-treated Plasma Unknown 100 ml —
Subject Spray-dried S/D-treated Plasma Unknown 200 ml —
Subject Spray-dried S/D-treated Plasma Unknown 500 ml —
Subject Spray-dried S/D-treated Plasma Unknown 750 ml —
Subject Spray-dried S/D-treated Plasma Unknown 800 ml —