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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Infusion of 100 mL Spray-dried S/D-treated Plasma
Infusion of 200mL Spray-dried S/D-treated plasma
Infusion of 500 mL Spray-dried S/D-treated plasma
Vince & Associates Clinical Research
Overland Park, Kansas, United States
Incidence of treatment-emergent SAEs
Incidence of treatment-emergent SAEs reported for up to 12 weeks post Resusix infusion
Time frame: 12 weeks
Change from baseline of select coagulation factors
To evaluate the recovery of select coagulation factors after infusion of 2 Resusix
Time frame: 30 minutes post infusion
Incidence of AEs
To evaluate the incidence of AEs for up to 12 weeks after infusion of Resusix
Time frame: 12 weeks
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Infusion of 750 mL Spray-dried S/D-treated Plasma
Infusion of 800 mL Spray-dried S/D-treated Plasma