Ascending Dose Study of FrontlineODP™ Spray Dried Plasma

Exclusion Criteria

• •Subject has known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune, or pulmonary disease, or treated or untreated hypertension
• •Subject has cancer of any kind, under treatment or resolved
• •Subject has known or past coagulopathy conditions
• •Subject has any conditions, uses medications, etc. on the AABB medical deferral list
• •Subject has a history of asthma (defined as use of a prescribed daily asthma controller medication or required asthma medication in the past 2 weeks)
• •Subject has a previous diagnosis of stroke, deep vein thrombosis (DVT), venous or arterial thrombosis, blood clots, or transient ischemic attack
• •Subject has a family history of venous or arterial thrombosis before the age of 50 years in first degree relatives (ie, biological parents, full siblings, or children)
• •Subject has a D-dimer test result ≥0.5 FEU/mL
• •Subject has a recent (within 1 year of Screening) history of an abnormal electrocardiogram of clinical significance as determined by the site PI
• •Subject has known HIV or AIDS-related illness or received a positive test result for HIV infection
• •Subject has a positive test result for HBV, hepatitis C virus (HCV), or human T-cell lymphotropic virus
• •Subject has a history of significant treated or untreated mental health issues
• •Subject is currently taking an antibiotic or another medication for an infection
• •Subject has received aspirin or other platelet-inhibiting agents within 14 days of study donation and infusion visits. Prior and concomitant medication information will be recorded beginning 30 days before enrollment through the final follow-up visit
• •Subject is currently using any medications for anticoagulant therapy
• •Subject has used clotting factor concentrates(s) (eg, FVIIa)
• •Subject has received blood or blood products within the past 12 months
• •Subject has had concurrent headache and fever in the past week
• •Subject has systolic blood pressure (current) greater than 140 mm Hg
• •Subject has diastolic blood pressure (current) greater than 90 mm Hg
• •Subject has an oral temperature greater than 100°F
• •Subject has known hematocrit ≤39% for male donors and ≤38% for female donors
• •Subject has a positive DAT result
• •Subject has received any investigational agent within 1 month before treatment infusion for this study
• •Subject is participating in any phase of any other investigational studies while participating in this study
• •Subject is unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits as scheduled
• •Subject has other unspecified reasons that, in the opinion of the site PI, make the subject unsuitable for enrollment
• •Subject is institutionalized because of legal or regulatory order
• •Subject has a positive urine drug screen