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

NCT01589666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-02-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Entegrion, Inc.

    lead INDUSTRY

Principal Investigators

  • Bradley Vince, DO · Vince & Associates Clinical Research, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-09-09
Completion
2016-09-09

Countries

  • United States

Study Locations

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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 NCT01589666 on ClinicalTrials.gov