Healthy
Conditions
Brief summary
This first-in-human exploratory IND, single-center study will assess the safety, toxicity, hematology, and immunogenicity of sub-therapeutic microdoses of autologous Thrombosomes® in healthy human subjects.
Interventions
BIOLOGICALThrombosomes
Freeze-dried platelets
BIOLOGICALPlacebo
Sponsors
Department of Health and Human Services
Cellphire Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Minimum weight 110 pounds (50 kg) 2. Age 18-45 years 3. Able and willing to provide informed consent 4. Has permanent address and phone/e-mail for contact and notification, and able to come to the research site for scheduled study visits for up to 60 days after their last study infusion 5. Understands, speaks and reads standard English language 6. Normal healthy subject able to pass the universal blood donor history questionnaire and screen
Exclusion criteria
1. Breast-feeding female 2. At any time, previously pregnant female 3. Participation in an experimental drug/device study within the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety Evaluation | 60 days |
Secondary
| Measure | Time frame |
|---|---|
| Standard Hematology, Coagulation and Platelet Immunology Assessment | 60 Days |
Countries
United States
Outcome results
None listed