Ascending Dose Study of FrontlineODP™ Spray Dried Plasma

NCT05629338 | Completed Phase 1 DMC FDA Device

• 1 other identifier: IDE 27346
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Coagulopathy; Hemorrhage

Keywords

dried plasma; coagulation function; plasmapheresis

Outcome Measures

Primary Outcomes (2)

• Occurrence of Treatment-Emergent Adverse Events (TEAEs)

  Conclusions about safety will be based on the occurrence of TEAEs in Cohort 1 (1 unit of FrontlineODP, 200 mL) and Cohort 2 (2 units of FrontlineODP, 400 mL).

  Start of plasma infusion through 28 day follow up (Day 29).

• Occurrence of Treatment-Emergent Adverse Events (TEAEs)

  Conclusions about safety will be based on the occurrence of TEAEs in Cohort 3 with infusions of 4 units (800 mL) of FrontlineODP compared to 4 units (800 mL) of PF24.

  Start of first plasma infusion through 28 day follow up of the second infusion (Day 43).

Secondary Outcomes (16)

• Changes in PT

  Start of first plasma infusion through 28-day follow up of second infusion (Day 43).

• Changes in INR

  Start of first plasma infusion through 28-day follow up of second infusion (Day 43).

• Changes in aPTT

  Start of first plasma infusion through 28-day follow up of second infusion (Day 43).

• Changes in Factor I

  Start of first plasma infusion through 28-day follow up of second infusion (Day 43).

• Changes in Factor II

  Start of first plasma infusion through 28-day follow up of second infusion (Day 43).

Study Arms (4)

Cohort 1

EXPERIMENTAL

Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 1 unit (200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

Combination Product: Autologous Spray Dried Plasma

Cohort 2

EXPERIMENTAL

Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection, in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 2 units (400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

Combination Product: Autologous Spray Dried Plasma

Cohort 3 Arm 3

ACTIVE COMPARATOR

Subject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and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

Combination Product: Autologous Spray Dried Plasma

Cohort 3 Arm 4

ACTIVE COMPARATOR

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.

Combination Product: Autologous Spray Dried Plasma

Interventions

Autologous Spray Dried Plasma COMBINATION_PRODUCT

Evaluation of the Safety of Ascending Doses of Autologous Spray Dried Plasma in Healthy Volunteers

Also known as: FrontlineODP Unit, Frontline On Demand Plasma Unit

Cohort 1; Cohort 2; Cohort 3 Arm 3; Cohort 3 Arm 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Velico Medical: lead

Study Sites (3)

Hoxworth Blood Center

Cincinnati, Ohio, 45267-0055, United States

Location

Versiti Blood Center of Wisconsin

Milwaukee, Wisconsin, 53233, United States

Location

Spaulding Clinical Research LLC

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Conditions

Hemostatic Disorders; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Popovsky, MD

  Velico Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For Cohorts 1 and 2, blinding is not necessary because subjects will only receive a single infusion of FrontlineODP. Cohort 3 subjects will be randomly assigned to a treatment sequence and will remain blinded to the study product they receive at each visit. Study participants, the Principal Investigators, the Independent Medical Monitor, and the Data Monitoring Committee will be blinded to the randomization treatment assignments throughout the study.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study in healthy volunteers (n=24) is designed to assess the safety of infusing ascending doses of reconstituted autologous FrontlineODP in 1, 2, and 4 fixed-dose units. Subjects in Cohort 1 (n = 6) will receive 1 unit of FrontlineODP (Arm 1), which is approximately 200 mL. Subjects in Cohort 2 (n = 6) will receive 2 FrontlineODP units (Arm 2) (total volume of approximately 400 mL). Cohort 3 is a crossover design where subjects (n = 12) will be randomly assigned to receive either 4 units of FrontlineODP followed 14 days later by 4 units of PF24 (Arm 3 - ODPxPF24), or 4 units of PF24 followed 14 days later by 4 units of FrontlineODP (Arm 4 - PF24xODP), where each infusion has a total volume of approximately 800 mL.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 29, 2022
• Study Start: December 1, 2022
• Primary Completion: March 18, 2025
• Study Completion: April 29, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)