NCT01589666

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Entegrion, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coagulation Defects

Interventions

Type	Name	Description
BIOLOGICAL	Spray-dried S/D-treated Plasma	Infusion of 100 mL Spray-dried S/D-treated Plasma
DRUG	Spray-dried S/D-treated plasma	Infusion of 200mL Spray-dried S/D-treated plasma
BIOLOGICAL	Spray-dried S/D-treated Plasma	Infusion of 500 mL Spray-dried S/D-treated plasma
BIOLOGICAL	Spray-dried S/D-treated Plasma	Infusion of 750 mL Spray-dried S/D-treated Plasma
BIOLOGICAL	Spray-dried S/D-treated Plasma	Infusion of 800 mL Spray-dried S/D-treated Plasma

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-09-09
• Completion: 2016-09-09
• First posted: 2012-05-02
• Last updated: 2017-02-07

Locations

1 site across 1 country: United States