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)

Cellphire Therapeutics

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Biological: Placebo; Biological: Thrombosomes

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02223117

2011-1

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Minimum weight 110 pounds (50 kg)
2. Age 18-45 years
3. Able and willing to provide informed consent
4. 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
5. Understands, speaks and reads standard English language
6. Normal healthy subject able to pass the universal blood donor history questionnaire and screen

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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15 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Thrombosomes

Treatment:

Biological: Thrombosomes

Placebo

Placebo Comparator group

Description:

Buffer/placebo Control

Treatment:

Biological: Placebo