FrontlineODP™ Spray Dried Plasma for Blood Clotting Disorders

Recruiting at 2 trial locations

Overseen By Lisa Buckley, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Velico Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Mark Popovsky, MD

Principal Investigator

Velico Medical

Eligibility Criteria

Healthy volunteers aged 18-65 who can consent, understand English, have completed COVID-19 vaccination, and meet specific weight requirements. Women must not be pregnant/breastfeeding and should use effective contraception or be sterile. Participants must feel well and score ≥35 on the Duke Activity Status Index.

Inclusion Criteria

I am a female weighing between 140-220 pounds or a male weighing between 140-250 pounds.

Subject is able to donate plasma by plasmapheresis based on AABB Donor History Questionnaire with modifications

Subject has read educational materials on donating blood and had questions answered

Exclusion Criteria

I have cancer.

Subject is institutionalized

Subject has a history of asthma

Treatment Details

Interventions

• FrontlineODP™ Spray Dried Plasma (Plasma)

Trial Overview The trial is testing FrontlineODP™ Spray Dried Plasma in healthy individuals to see if different doses are safe when infused into the body. It's for people with bleeding or blood clotting disorders.

Participant Groups

Group I: Cohort 2 Experimental Treatment 1 Intervention

Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection, in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 2 units (400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

Group II: Cohort 1 Experimental Treatment 1 Intervention

Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 1 unit (200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

Group III: Cohort 3 Arm 3 Active Control 1 Intervention

Subject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and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.

Group IV: Cohort 3 Arm 4 Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Velico Medical

Lead Sponsor

Trials

2

Recruited

80+