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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)

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ClinicalTrials.gov Identifier: NCT02223117
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Cellphire, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Thrombosomes Biological: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 2014
Actual Primary Completion Date : July 21, 2016
Actual Study Completion Date : July 21, 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Thrombosomes
 Biological: Thrombosomes
Freeze-dried platelets
Placebo Comparator: Placebo
Buffer/placebo Control
 Biological: Placebo
Other Name: Buffer/placebo Control


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety Evaluation [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Standard Hematology, Coagulation and Platelet Immunology Assessment [ Time Frame: 60 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223117


Locations
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United States, Washington
Bloodworks Northwest
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Cellphire, Inc.
Department of Health and Human Services
Investigators
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Study Director: Michael Fitzpatrick, PhD Cellphire, Inc.
Principal Investigator: Sherrill Slichter, MD Bloodworks Northwest
More Information
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Responsible Party: Cellphire, Inc.
ClinicalTrials.gov Identifier: NCT02223117    
Other Study ID Numbers: 2011-1
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017