Ascending Dose Study of FrontlineODP™ Spray Dried Plasma

Velico Medical

Status and phase: Completed; Phase 1

Conditions: Hemorrhage; Coagulopathy

Treatments: Combination Product: Autologous Spray Dried Plasma

Study type: Interventional

Funder types: Industry

Identifiers

NCT05629338

IDE 27346

Details and patient eligibility

About

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

Full description

This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP). Volunteers will have their plasma collected, spray dried, and then rehydrated for infusion. Volunteers will be infused with their own (autologous) rehydrated plasma. Cohort 1 will receive 1 FrontlineODP unit that is rehydrated to approximately 200 mL. Cohort 2 will receive 2 FrontlineODP units of approximately 400 mL. Cohort 3 volunteers will receive 2 separate infusions of 4 units of approximately 800 mL of either FrontlineODP (experimental) or frozen plasma (PF24). Order of receipt of plasma product will be randomized with 14 days between infusion.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and nonpregnant/nonbreastfeeding females
• For 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 pounds
• Subject is 18 to 65 years of age, inclusive
• Subject self-reports that he or she feels well and healthy
• Subject scores ≥35 on the Duke Activity Status Index
• Subject 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 participate
• Subject 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 enrollment
• Subject has read the educational materials on donating blood and has had his or her questions answered
• Subject is able and willing to provide written informed consent
• 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 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 partner
• All females must have a negative urine or serum pregnancy test
• Subject understands the English language

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 1 unit (200 mL) of autologous FrontlineODP.

Treatment:

Combination Product: Autologous Spray Dried Plasma

Cohort 2

Experimental group

Description:

Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection, in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 2 units (400 mL) of autologous FrontlineODP.

Treatment:

Combination Product: Autologous Spray Dried Plasma

Cohort 3 Arm 3

Active Comparator group

Description:

Subject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and hematocrit, to allow re-infusion with 4 units of autologous FrontlineODP and 4 units of autologous control PF24. Subjects will receive in total 8 units of plasma over the course of 2 infusion visits. Subjects randomized to Arm 3 will receive 4 units of FrontlineODP during the first infusion visit, and following a 14 day washout period, they would receive 4 units of PF24 during a second visit.

Treatment:

Combination Product: Autologous Spray Dried Plasma

Cohort 3 Arm 4

Active Comparator group

Description:

Subject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and hematocrit, to allow re-infusion with 4 units of autologous control PF24 and 4 units of autologous FrontlineODP. Subjects will receive in total 8 units of plasma over the course of 2 infusion visits. Subjects randomized to Arm 4 will receive 4 units of PF24 during the first infusion visit, and following a 14 day washout period, they would receive 4 units of FrontlineODP during the second visit.

Treatment:

Combination Product: Autologous Spray Dried Plasma