Ascending Dose Study of FrontlineODP™ Spray Dried Plasma

Status Enrolling by invitation

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05629338
Study type	Interventional
Source	Velico Medical
Contact
Status	Enrolling by invitation
Phase	Phase 1
Start date	December 1, 2022
Completion date	May 15, 2024

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