Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)
This trial is active, not recruiting.
|Collaborator||Department of Health and Human Services|
|Start date||September 2014|
|End date||July 2016|
|Trial size||15 participants|
|Trial identifier||NCT02223117, 2011-1|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
|Masking||single blind (subject)|
Number of Participants with Adverse Events as a Measure of Safety Evaluation
time frame: 60 days
Standard Hematology, Coagulation and Platelet Immunology Assessment
time frame: 60 Days
Male or female participants from 18 years up to 45 years old.
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.
|Official title||Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)|
|Principal investigator||Sherrill Slichter, MD|
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