Trial Outcomes & Findings for Ascending Doses of Autologous FDP vs FFP (NCT NCT02930226)

Last Updated: 2021-02-12

Results Overview

Assess the safety of single infusions of FDP at increasing fixed doses of either 1 unit, 2 units, or 3 units in normal healthy subjects by evaluating vital signs during and after infusion

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4

Results posted on

2021-02-12

Participant Flow

Healthy volunteers were recruited at an academic medical center between February 2017 and March 2018. The first participant was enrolled on March 6, 2017 and the last participant was enrolled on April 5, 2018.

Of 40 screened participants, 30 met inclusion criteria and were enrolled. Six participants were withdrawn prior to receiving study treatment. Twenty four participants were infused with plasma.

Participant milestones

Participant milestones
Measure	1 Unit, Single Infusion FDP-CPD Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	1 Unit, Single Infusion FDP-ACD Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-CPD Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-ACD Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	3 Units Per Crossover Infusion FDP-ACD x FFP Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only	3 Units Per Crossover Infusion FFP x FDP-ACD Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only
Overall Study STARTED	4	4	4	4	4	4
Overall Study COMPLETED	4	4	4	4	3	4
Overall Study NOT COMPLETED	0	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	1 Unit, Single Infusion FDP-CPD Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	1 Unit, Single Infusion FDP-ACD Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-CPD Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-ACD Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	3 Units Per Crossover Infusion FDP-ACD x FFP Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only	3 Units Per Crossover Infusion FFP x FDP-ACD Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only
Overall Study Technical Problems: Leak in plasma bag	0	0	0	0	1	0

Baseline Characteristics

Female participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Unit, Single Infusion FDP-CPD n=4 Participants Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	1 Unit, Single Infusion FDP-ACD n=4 Participants Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-CPD n=4 Participants Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-ACD n=4 Participants Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	3 Units Per Crossover Infusion FDP-ACD x FFP n=4 Participants Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only	3 Units Per Crossover Infusion FFP x FDP-ACD n=4 Participants Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only	Total n=24 Participants Total of all reporting groups
Age, Continuous	34.8 years STANDARD_DEVIATION 7.0 • n=4 Participants	34.3 years STANDARD_DEVIATION 9.9 • n=4 Participants	33.5 years STANDARD_DEVIATION 4.8 • n=4 Participants	33.8 years STANDARD_DEVIATION 17.9 • n=4 Participants	35.8 years STANDARD_DEVIATION 6.1 • n=4 Participants	32.0 years STANDARD_DEVIATION 10.7 • n=4 Participants	34.03 years STANDARD_DEVIATION 10.30 • n=24 Participants
Sex: Female, Male Female	2 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	3 Participants n=24 Participants
Sex: Female, Male Male	2 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	3 Participants n=4 Participants	21 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	24 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=24 Participants
Race (NIH/OMB) White	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	3 Participants n=4 Participants	23 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=24 Participants
Region of Enrollment United States	4 participants n=4 Participants	4 participants n=4 Participants	4 participants n=4 Participants	4 participants n=4 Participants	4 participants n=4 Participants	4 participants n=4 Participants	24 participants n=24 Participants
Body Mass Index (BMI)	27.0 kg/m^2 STANDARD_DEVIATION 4.1 • n=4 Participants	27.4 kg/m^2 STANDARD_DEVIATION 1.3 • n=4 Participants	26.2 kg/m^2 STANDARD_DEVIATION 4.8 • n=4 Participants	26.3 kg/m^2 STANDARD_DEVIATION 4.2 • n=4 Participants	28.8 kg/m^2 STANDARD_DEVIATION 3.6 • n=4 Participants	27.8 kg/m^2 STANDARD_DEVIATION 2.3 • n=4 Participants	27.25 kg/m^2 STANDARD_DEVIATION 3.57 • n=24 Participants
Height	172.7 cm STANDARD_DEVIATION 7.5 • n=4 Participants	185.4 cm STANDARD_DEVIATION 5.5 • n=4 Participants	187.3 cm STANDARD_DEVIATION 8.4 • n=4 Participants	177.8 cm STANDARD_DEVIATION 3.6 • n=4 Participants	180.4 cm STANDARD_DEVIATION 3.6 • n=4 Participants	182.2 cm STANDARD_DEVIATION 11.8 • n=4 Participants	180.97 cm STANDARD_DEVIATION 7.34 • n=24 Participants
Weight	80.2 Kg STANDARD_DEVIATION 10.3 • n=4 Participants	94.1 Kg STANDARD_DEVIATION 7.1 • n=4 Participants	91.6 Kg STANDARD_DEVIATION 15.2 • n=4 Participants	83.1 Kg STANDARD_DEVIATION 13.4 • n=4 Participants	93.4 Kg STANDARD_DEVIATION 8.3 • n=4 Participants	92.2 Kg STANDARD_DEVIATION 8.9 • n=4 Participants	89.1 Kg STANDARD_DEVIATION 10.86 • n=24 Participants
Childbearing Potential Yes	1 Participants n=2 Participants • Female participants	0 Participants Female participants	0 Participants Female participants	0 Participants Female participants	0 Participants Female participants	1 Participants n=1 Participants • Female participants	2 Participants n=3 Participants • Female participants
Childbearing Potential No	1 Participants n=2 Participants • Female participants	0 Participants Female participants	0 Participants Female participants	0 Participants Female participants	0 Participants Female participants	0 Participants n=1 Participants • Female participants	1 Participants n=3 Participants • Female participants
Rh Factor Positive	2 Participants n=4 Participants	4 Participants n=4 Participants	3 Participants n=4 Participants	2 Participants n=4 Participants	3 Participants n=4 Participants	4 Participants n=4 Participants	18 Participants n=24 Participants
Rh Factor Negative	2 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	2 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	6 Participants n=24 Participants
Blood Type A	3 Participants n=4 Participants	2 Participants n=4 Participants	3 Participants n=4 Participants	0 Participants n=4 Participants	2 Participants n=4 Participants	2 Participants n=4 Participants	12 Participants n=24 Participants
Blood Type B	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	2 Participants n=24 Participants
Blood Type AB	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	3 Participants n=24 Participants
Blood Type O	0 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=4 Participants	2 Participants n=4 Participants	2 Participants n=4 Participants	1 Participants n=4 Participants	7 Participants n=24 Participants
History of any diseases and/or surgeries Yes	3 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	3 Participants n=4 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	22 Participants n=24 Participants
History of any diseases and/or surgeries No	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	2 Participants n=24 Participants

PRIMARY outcome

Timeframe: Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4

Assess the safety of single infusions of FDP at increasing fixed doses of either 1 unit, 2 units, or 3 units in normal healthy subjects by evaluating vital signs during and after infusion

Outcome measures

Outcome measures
Measure	1 Unit, Single Infusion FDP-CPD n=4 Participants Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	1 Unit, Single Infusion FDP-ACD n=4 Participants Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-CPD n=4 Participants Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-ACD n=4 Participants Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	3 Units Per Crossover Infusion FDP-ACD x FFP n=4 Participants Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only	3 Units Per Crossover Infusion FFP x FDP-ACD n=4 Participants Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only
Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests	4 Participants	4 Participants	4 Participants	4 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Follow-up assessments on days 2, 8, 16, 22, 43, and telephone assessments on days 3, 4, 17, and 18

Assess the safety and tolerability of a fixed-dose infusion of 3 FDP units in comparison to infusion with the same dose of autologous Fresh Frozen Plasma (FFP) in normal healthy subjects by evaluating vital signs and laboratory tests

Outcome measures

Outcome measures
Measure	1 Unit, Single Infusion FDP-CPD n=4 Participants Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	1 Unit, Single Infusion FDP-ACD n=4 Participants Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-CPD Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-ACD Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	3 Units Per Crossover Infusion FDP-ACD x FFP Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only	3 Units Per Crossover Infusion FFP x FDP-ACD Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only
Number of Participants With Treatment-emergent Adverse Events	3 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.

Determine if the changes in specific coagulation values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Blood thrombin, Coombs direct test, Fibrin D dimer, and Thrombin-antithrombin III levels are determined through a blood test to check if your blood is clotting normally. Positive tests or any values below or above the normal reference range is considered abnormal.

Outcome measures

Outcome measures
Measure	1 Unit, Single Infusion FDP-CPD n=4 Participants Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	1 Unit, Single Infusion FDP-ACD n=4 Participants Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-CPD n=4 Participants Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-ACD n=4 Participants Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	3 Units Per Crossover Infusion FDP-ACD x FFP n=3 Participants Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only	3 Units Per Crossover Infusion FFP x FDP-ACD n=4 Participants Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only
Number of Participants With Significant Changes in Specific Coagulation Values Blood thrombin increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Significant Changes in Specific Coagulation Values Coombs direct test positive	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Significant Changes in Specific Coagulation Values Fibrin D dimer increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Significant Changes in Specific Coagulation Values Thrombin-antithrombin III increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.

Determine if the changes in specific hematology values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. The specific hematology values are determined through a blood test. Any values below or above the normal reference range is considered abnormal.

Outcome measures

Outcome measures
Measure	1 Unit, Single Infusion FDP-CPD n=4 Participants Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	1 Unit, Single Infusion FDP-ACD n=4 Participants Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-CPD n=4 Participants Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	2 Units, Single Infusion FDP-ACD n=4 Participants Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers	3 Units Per Crossover Infusion FDP-ACD x FFP n=3 Participants Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only	3 Units Per Crossover Infusion FFP x FDP-ACD n=4 Participants Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only
Number of Participants With Significant Changes in Specific Hematology Values	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.

Determine if the changes in specific chemistry values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Glucose levels and liver function levels, ALT and AST, are determined through a blood test. Any values below or above the normal reference range is considered abnormal.