Ascending Doses of Autologous FDP vs FFP

This is a single-site, single-blind study in healthy volunteers and is designed to assess the
safety of infusing ascending doses of reconstituted autologous FDP in 3 fixed-dose cohorts.
Subjects in Cohort 1 will receive 1 unit of FDP, which is approximately 270 mL. Subjects in
Cohort 2 will receive 2 FDP units, which total approximately 540 mL. Cohorts 1 and 2 are the
lower-dose cohorts. Subjects will be assigned to these beginning with the lowest dose, Cohort
1. In the absence of SAEs or the implementation of protocol stopping rules (SRs), subjects
will be assigned to Cohort 2, where the dose is increased to 2 units. For both of these
cohorts subjects will also be assigned to 1 of 2 single infusion treatment arms.

Inclusion Criteria:

- Males and non-pregnant/non-breastfeeding females;

- Minimum weight is 140 pounds, maximum weight is 220 pounds;

- Ages 18-55 years;

- Self-reports that he or she feels well and healthy;

- Scores ≥ 35 on the Duke Activity Status Index;

- Able to donate 1 unit of WB based on the AABB donor history questionnaire with
modifications indicated. Subjects with history of travel which puts them at risk for
Creutzfeldt-Jakob Disease (CJD) or malaria will be eligible to participate;

- Has read the educational materials on donating blood and has had his or her questions
answered;

- Able and willing to provide written informed consent;

- Available for the duration of the trial, which is approximately 12 weeks for subjects
in Cohort 1 and Cohort 2, Arm 4; approximately 16 weeks for Cohort 2, Arm 3 and Cohort
3 (includes time for collections, product manufacture, and infusions), and able to
come to the treatment clinic for scheduled study visits;

- Females 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 lower failure rate (i.e., less than 1% per year) when used consistently and
correctly such as implants, injectables, combined oral contraceptives, some
intrauterine devices, sexual abstinence, or vasectomized partner;

- All females must have a negative urine pregnancy test prior to enrollment; and

- Understands the English language.

Exclusion Criteria:

- Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood,
endocrine/metabolic, autoimmune or pulmonary disease, or treated or untreated
hypertension;

- Cancer of any kind, under treatment or resolved;

- Known or past coagulopathy conditions;

- Any conditions, medications, etc. on the AABB medical deferral list;

- Past history of asthma (defined as use of a prescribed daily asthma controller
medication or required asthma medication in the past 2 weeks);

- Past diagnosis of stroke, deep vein thrombosis, or transient ischemic attack

- Family history of venous or arterial thrombosis before the age of 50 in first-degree
relatives (i.e., biological parents, full siblings, or children);

- History of abnormal electrocardiogram (EKG);

- Current smoker (defined as having smoked within the last 6 months);

- Known Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome
(AIDS)-related illness or received a positive test result for HIV infection;

- Positive test for Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) or Human T-cell
Lymphotropic Virus (HTLV);

- History or significant treated or untreated mental health issues;

- Female subject who is pregnant, lactating, or with a positive pregnancy test;

- Currently taking an antibiotic or another medication for an infection;

- Treatment or use of aspirin (or other platelet inhibiting agents) within 14 days of
study donation and infusion visits;

- Currently using any medications for anticoagulant therapy;

- Previous use of clotting factor concentrate(s);

- Receipt of blood or blood products within the past 12 months;

- In the past week, has had a headache and fever at the same time;

- Known intolerance to any excipients (citrate) in the study drug formulation;

- Systolic blood pressure greater than 140 mmHg;

- Diastolic blood pressure greater than 90 mmHg;

- Temperature greater than 100°F;

- Known hematocrit less than 38% for both male and female donors;

- Positive direct antiglobulin test (DAT);

- Treatment with any investigational agent within 1 month before treatment infusion for
this trial;

- Participation in any phase of any other investigational trials while participating in
this trial;

- 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 on schedule;

- Other unspecified reasons that, in the opinion of the PI, make the subject unsuitable
for enrollment; or

- Institutionalized because of legal or regulatory order.