Trials / Completed
CompletedNCT02223117
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)
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Cellphire Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Thrombosomes | Freeze-dried platelets |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2016-07-21
- Completion
- 2016-07-21
- First posted
- 2014-08-22
- Last updated
- 2017-12-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02223117. Inclusion in this directory is not an endorsement.