The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Single or multiple doses of ALN-PCSSC by subcutaneous (sc) injection
calculated volume to match active comparator
Covance Clinical Research Unit
Leeds, United Kingdom
Richmond Pharmacology
London, United Kingdom
The safety of ALN-PCSSC evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation
Time frame: Part 1 (SAD phase): up to 180 days post dose; Part 2 (MD) phase: up to 180 days post final dose
The pharmacokinetics (PK) of ALN-PCSSC (Cmax, tmax, AUC, t1/2)
Time frame: Part 1 (SAD) phase: predose, 0.5,1,2,4,6,8,12,24,48,72,96 hours; 7, 14, 21, 28, 42, 56 days post-dose; Part 2 (MD) phase: predose, 0.5,1,2,4,6,8,12,24,48,72,96 hours; 7, 14, 21, 28, 29, 35, 42, 56, 84 days post-dose
The effect of ALN-PCSSC on serum levels of LDL-C
Time frame: Through the sooner of final follow up visit or 180 days post final dose
The effect of ALN-PCSSC on plasma levels of PCSK9
Time frame: Through the sooner of final follow up visit or 180 days post final dose
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