The Safety of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Healthy Volunteers

This "first-in-human" Phase I, single-center, dose escalation study (using 3 dose levels) is
proposed to assess the safety of infusing reconstituted lyophilized human plasma (LyP). The
study design incorporates plasmapheresis-derived autologous plasma (FFP) for infusion(s) to
eliminate variables and events known to be related to allogenic transfusion. Subjects will
be enrolled at a blood center and provide autologous FFP that will be shipped to the sponsor
site and used as the starting material to manufacture LyP. Once manufacturing is complete,
the LyP (autologous) will be returned to the blood center for reconstitution and infusion
into subjects. Maximum dosage within this study will approach "massive transfusion" (1 liter
in Cohort 3) to obtain a preliminary assessment of safety. One half of the FFP obtained from
subjects in Cohort 3 (only) will be shipped to the sponsor and returned to the site (but not
manufactured into LyP) to serve as the control (autologous FFP).