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)
NCT ID: NCT02223117
Last Updated: 2017-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
15 participants
INTERVENTIONAL
2014-09-30
2016-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Intervention
Thrombosomes
Thrombosomes
Freeze-dried platelets
Placebo
Buffer/placebo Control
Placebo
Interventions
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Thrombosomes
Freeze-dried platelets
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. At any time, previously pregnant female
3. Participation in an experimental drug/device study within the past 30 days.
18 Years
45 Years
ALL
Yes
Sponsors
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Department of Health and Human Services
FED
Cellphire Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Fitzpatrick, PhD
Role: STUDY_DIRECTOR
Cellphire Therapeutics, Inc.
Sherrill Slichter, MD
Role: PRINCIPAL_INVESTIGATOR
Bloodworks Northwest
Locations
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Bloodworks Northwest
Seattle, Washington, United States
Countries
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Other Identifiers
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2011-1
Identifier Type: -
Identifier Source: org_study_id