Ascending Dose Study of FrontlineODP™ Spray Dried Plasma

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

Inclusion Criteria:Males and nonpregnant/nonbreastfeeding femalesFor females, a minimum weight of 140 pounds and maximum weight of 220 pounds; for males, a minimum weight of 140 pounds and a maximum weight of 250 poundsSubject is 18 to 65 years of age, inclusiveSubject self-reports that he or she feels well and healthySubject scores ≥35 on the Duke Activity Status IndexSubject is able to donate a unit of plasma by plasmapheresis based on the AABB Donor History Questionnaire with modifications indicated: subjects with history of travel, which puts them at risk for Creutzfeldt-Jakob Disease or malaria, are eligible to participateSubject has completed a vaccination course for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), with the final vaccine injection administered at least 2 weeks before enrollmentSubject has read the educational materials on donating blood and has had his or her questions answeredSubject is able and willing to provide written informed consentFemales of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation) or should use a highly effective medically accepted contraceptive regimen. Highly effective methods of birth control are defined as those which result in a low failure rate (ie, less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, condoms with spermicide, or vasectomized partnerAll females must have a negative urine or serum pregnancy testSubject understands the English languageExclusion Criteria:Subject has known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune, or pulmonary disease, or treated or untreated hypertensionSubject has cancer of any kind, under treatment or resolvedSubject has known or past coagulopathy conditionsSubject has any conditions, uses medications, etc. on the AABB medical deferral listSubject 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 attackSubject 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/mLSubject has a recent (within 1 year of Screening) history of an abnormal electrocardiogram of clinical significance as determined by the site PISubject has known HIV or AIDS-related illness or received a positive test result for HIV infectionSubject has a positive test result for HBV, hepatitis C virus (HCV), or human T-cell lymphotropic virusSubject has a history of significant treated or untreated mental health issuesSubject is currently taking an antibiotic or another medication for an infectionSubject 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 visitSubject is currently using any medications for anticoagulant therapySubject has used clotting factor concentrates(s) (eg, FVIIa)Subject has received blood or blood products within the past 12 monthsSubject has had concurrent headache and fever in the past weekSubject has systolic blood pressure (current) greater than 140 mm HgSubject has diastolic blood pressure (current) greater than 90 mm HgSubject has an oral temperature greater than 100°FSubject has known hematocrit ≤39% for male donors and ≤38% for female donorsSubject has a positive DAT resultSubject has received any investigational agent within 1 month before treatment infusion for this studySubject is participating in any phase of any other investigational studies while participating in this studySubject 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 scheduledSubject has other unspecified reasons that, in the opinion of the site PI, make the subject unsuitable for enrollmentSubject is institutionalized because of legal or regulatory orderSubject has a positive urine drug screen