This trial is active, not recruiting.

Condition healthy
Treatments thrombosomes, placebo
Phase phase 0
Sponsor Cellphire, Inc.
Collaborator Department of Health and Human Services
Start date September 2014
End date July 2016
Trial size 15 participants
Trial identifier NCT02223117, 2011-1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
Freeze-dried platelets
(Placebo Comparator)
Buffer/placebo Control
Freeze-dried platelets
placebo Buffer/placebo Control

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety Evaluation
time frame: 60 days

Secondary Outcomes

Standard Hematology, Coagulation and Platelet Immunology Assessment
time frame: 60 Days

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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.

Additional Information

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)
Principal investigator Sherrill Slichter, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Cellphire, Inc..