Ascending Dose Study of FrontlineODP™ Spray Dried Plasma

Completed · Phase 1

Conditions studied: Coagulopathy, Hemorrhage

In brief

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

Key facts

Study ID: NCT05629338
Run by: Velico Medical
People needed: 24
Starts: 2022-12-01
Expected to finish: 2025-04-29
Last updated by the study team: 2025-09-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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
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

Where it is running

Hoxworth Blood Center — Cincinnati, Ohio, United States
Versiti Blood Center of Wisconsin — Milwaukee, Wisconsin, United States
Spaulding Clinical Research LLC — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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