Study Complete
Sponsor ID
20080398
Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults with Hyperlipidemia on Stable Doses of a Statin
Study Details
The purpose of the study is to evaluate the safety and tolerability of multiple doses of evolocumab when given as an add-on to stable statin therapy.
Protocol Summary
Primary Outcome Measures
The subject incidence of treatment-emergent adverse events and incidence of binding and neutralizing antibodies to AMG 145 as well as changes in vital signs, clinical laboratory safety tests, and electrocardiograms (ECGs).
Timeframe: Including a 35-day screening period, the maximum subject participation is 120 days.
Secondary Outcome Measures
PK (pharmacokinetics) concentrations as well as derived PK parameters of unbound AMG 145
Timeframe: Including a 35-day screening period, the maximum subject participation is 120 days.
Ratio to baseline and unadjusted LDL-C and PCSK9 (proprotein convertase subtilisin/kexin type 9)
Timeframe: Including a 35-day screening period, the maximum subject participation is 120 days.
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.