The primary objective of this study is to evaluate the safety and tolerability of repeated doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Incidence of dose limiting or intolerable treatment related adverse events (AEs).
Time frame: Every Scheduled Visit
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
Time frame: Every Scheduled Visit
Incidence of abnormal and clinically relevant safety laboratories.
Time frame: Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197
Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
Time frame: Every Scheduled Visit
Incidence of anti-drug-antibodies.
Time frame: Baseline and Day 15 and monthly thereafter
PK parameter estimates including but not be limited to: AUC, Tmax, Cmax terminal elimination half life (t1/2), Clearance (CL), volume of distribution at steady state (Vss), and accumulation ratio (R) of RN316.
Time frame: Day 1 and every scheduled visit thereafter
Absolute and percentage change in LDL C from baseline.
Time frame: Every scheduled visit except Day 1
Proportion of subjects who achieve a target LDL C of <100 mg/mL.
Time frame: Every scheduled visit except Day 1
Proportion of subjects who achieve a target LDL C of <70 mg/dL.
Time frame: Every scheduled visit except Day 1
Proportion of subjects achieving 50% decrease in LDL C from baseline.
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Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
Time frame: Every scheduled visit except Day 1