At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
3K3A-APC, diluted in 0.9% sodium chloride in water +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 Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC, a Recombinant Variant of Human Activated Protein C (APC), in Healthy Adult Volunteers
In Brief
A Phase 1 clinical trial evaluating 3K3A-APC, diluted in 0.9% sodium chloride in water and 0.9% NaCl in water for Healthy. Completed, enrolled 64 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesAustria
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedAug 2012
Primary CompletionDec 2012
TodayJul 2026
First PostedAug 8, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.9 years ago
Interventions
3K3A-APC, diluted in 0.9% sodium chloride in waterbiological
0.9% NaCl in waterdrug