Skip to main content
OpenTrials
Completed

NCT Number: NCT02223117

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Bloodworks Northwest

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thrombosomes

Biological

Freeze-dried platelets

Placebo

Biological

Other names: Buffer/placebo Control

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety Evaluation

    Time frame: 60 days

Secondary outcomes

  1. Standard Hematology, Coagulation and Platelet Immunology Assessment

    Time frame: 60 Days

Sponsors and collaborators

Lead sponsor

Cellphire Therapeutics, Inc.

Industry

Collaborators

  • Department of Health and Human Services

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2014
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.