NCT05629338

Ascending Dose Study of FrontlineODP™ Spray Dried Plasma

Evaluation for the Safety of FrontlineODP™ in a Multidose Randomized Cohort Study Compared With PF24

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Velico Medical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP).

Detailed description

This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP). Volunteers will have their plasma collected, spray dried, and then rehydrated for infusion. Volunteers will be infused with their own (autologous) rehydrated plasma. Cohort 1 will receive 1 FrontlineODP unit that is rehydrated to approximately 200 mL. Cohort 2 will receive 2 FrontlineODP units of approximately 400 mL. Cohort 3 volunteers will receive 2 separate infusions of 4 units of approximately 800 mL of either FrontlineODP (experimental) or frozen plasma (PF24). Order of receipt of plasma product will be randomized with 14 days between infusion.

Conditions

• Coagulopathy
• Hemorrhage

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Autologous Spray Dried Plasma	Evaluation of the Safety of Ascending Doses of Autologous Spray Dried Plasma in Healthy Volunteers

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-03-18
• Completion: 2025-04-29
• First posted: 2022-11-29
• Last updated: 2025-09-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study