Trial | NCT02223117  Report issue

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)

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    platelets ...

  • Study Participants

    15
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.
Study Started
Sep 30
2014
Primary Completion
Jul 21
2016
Study Completion
Jul 21
2016
Last Update
Dec 13
2017

Biological Thrombosomes

Freeze-dried platelets

Biological Placebo

  • Other names: Buffer/placebo Control

Intervention Experimental

Thrombosomes

Placebo Placebo Comparator

Buffer/placebo Control

Criteria 

Inclusion Criteria:

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 Criteria:

Breast-feeding female
At any time, previously pregnant female
Participation in an experimental drug/device study within the past 30 days.
No Results Posted