At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Autologous Freeze Dried Plasma (FDP) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Single-Center, Partial Double-Blind, Randomized, Controlled (Versus Fresh Frozen Plasma [FFP] in Cohort 3 Only) Clinical Study of the Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
U.S. Army Medical Research and Development Command·interventional·Posted Oct 12, 2016·Updated Feb 12, 2021
In Brief
A Phase 1 clinical trial evaluating Autologous Freeze Dried Plasma (FDP) and Fresh Frozen Plasma (FFP) for Freeze Dried Plasma in Healthy Volunteers. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Assess the safety of single infusions with RePlas FDP product at increasing fixed doses
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartFeb 2017
Primary CompletionAug 2018
TodayJul 2026
First PostedOct 12, 2016
Enrollment StartFeb 13, 2017
Primary CompletionAug 2, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.7 years ago
Interventions
Autologous Freeze Dried Plasma (FDP)biological
Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
Fresh Frozen Plasma (FFP)biological
Controlled FFP in cohort 3 only