NCT02223117

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1 healthy

Timeline
Completed

Started Sep 2014

Typical duration for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2016

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

August 15, 2014

Last Update Submit

December 11, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety Evaluation

    60 days

Secondary Outcomes (1)

  • Standard Hematology, Coagulation and Platelet Immunology Assessment

    60 Days

Study Arms (2)

Intervention

EXPERIMENTAL

Thrombosomes

Biological: Thrombosomes

Placebo

PLACEBO COMPARATOR

Buffer/placebo Control

Biological: Placebo

Interventions

ThrombosomesBIOLOGICAL

Freeze-dried platelets

Intervention
PlaceboBIOLOGICAL
Also known as: Buffer/placebo Control
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bloodworks Northwest

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

Buffers

Intervention Hierarchy (Ancestors)

Laboratory ChemicalsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Michael Fitzpatrick, PhD

    Cellphire Therapeutics, Inc.

    STUDY DIRECTOR

  • Sherrill Slichter, MD

    Bloodworks Northwest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2014

First Posted

August 22, 2014

Study Start

September 1, 2014

Primary Completion

July 21, 2016

Study Completion

July 21, 2016

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

US(1)