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 0 Completed 15 enrolled Cellphire Therapeutics, Inc. Department of Health and Human Services · collab

RandomizedSingle-groupSingle-blindTreatment

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.

Timeline

Start: 2014-09
Primary completion: 2016-07-21
Completion: 2016-07-21

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Thrombosomes	Other / unclassified	—	—

Indications

No indication recorded.