Ascending Dose Study of FrontlineODP™ Spray Dried Plasma
NCT05629338 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-09-18
Summary
This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP).
Conditions
- Coagulopathy
- Hemorrhage
Interventions
- COMBINATION_PRODUCT
-
Autologous Spray Dried Plasma
Evaluation of the Safety of Ascending Doses of Autologous Spray Dried Plasma in Healthy Volunteers
Sponsors & Collaborators
-
Velico Medical
lead INDUSTRY
Principal Investigators
-
Mark Popovsky, MD · Velico Medical
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-12-01
- Primary Completion
- 2025-03-18
- Completion
- 2025-04-29
- FDA Device
- Yes
Countries
- United States
Study Locations
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