MedTrace Logo

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)

NCT02223117 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-12-13

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Thrombosomes

Freeze-dried platelets

BIOLOGICAL

Placebo

Sponsors & Collaborators

Principal Investigators

  • Michael Fitzpatrick, PhD · Cellphire Therapeutics, Inc.

  • Sherrill Slichter, MD · Bloodworks Northwest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-07-21
Completion
2016-07-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02223117 on ClinicalTrials.gov