At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 49 enrolled
Drug / intervention
PF-04950615 (RN316) +3 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, Open-label, Randomized, Single Dose, Parallel Group Study To Assess The Pharmacokinetics And Pharmacodynamics Of Pf-04950615 Following Subcutaneous And Intravenous Doses In Adult Subjects With Hypercholesterolemia
In Brief
A Phase 1 clinical trial evaluating PF-04950615 (RN316) for Hypercholesterolemia and 4 related conditions. Completed, enrolled 49 participants across 7 sites.
Detailed Summary
This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615 (RN316) in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Dyslipidemias, Hyperlipidemias, Lipid Metabolism Disorders, Metabolic Diseases
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartOct 2011
Primary CompletionFeb 2012
Study CompletionApr 2012
TodayJul 2026
First PostedSep 16, 2011
Enrollment StartOct 1, 2011
Primary CompletionFeb 1, 2012
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.8 years ago
Interventions
PF-04950615 (RN316)biological
Dose A - single-dose intravenous infusion
PF-04950615 (RN316)biological
Dose B - single-dose subcutaneous injection
PF-04950615 (RN316)biological
Dose C - single-dose subcutaneous injection
PF-04950615 (RN316)biological
Dose D - single-dose subcutaneous injection