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)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 12/15/2017 |
| Start Date: | September 2014 |
| End Date: | July 21, 2016 |
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.
hematology, and immunogenicity of sub-therapeutic "microdoses" of autologous Thrombosomes® in
healthy human subjects.
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.
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