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)

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02223117

Run by

Cellphire Therapeutics, Inc.

People needed

15

Starts

2014-09-01

Expected to finish

2016-07-21

Last updated by the study team

2017-12-13

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Breast-feeding female
• At any time, previously pregnant female
• Participation in an experimental drug/device study within the past 30 days.

Where it is running

• Bloodworks Northwest — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.