Status:
COMPLETED
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)
Lead Sponsor:
Cellphire Therapeutics, Inc.
Collaborating Sponsors:
Department of Health and Human Services
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- Minimum weight 110 pounds (50 kg)
- Age 18-45 years
- Able and willing to provide informed consent
- 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
- Understands, speaks and reads standard English language
- Normal healthy subject able to pass the universal blood donor history questionnaire and screen
Exclusion
- Breast-feeding female
- At any time, previously pregnant female
- Participation in an experimental drug/device study within the past 30 days.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02223117
Start Date
September 1 2014
End Date
July 21 2016
Last Update
December 13 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bloodworks Northwest
Seattle, Washington, United States, 98104