Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia, Dyslipidemia, LDL, Cholesterol, High Cholesterol
Brief summary
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.
Interventions
BIOLOGICALPlacebo
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.
BIOLOGICAL1 mg/kg every 2 weeks
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.
BIOLOGICAL2 mg/kg every 4 weeks
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.
BIOLOGICAL4 mg/kg every 4 weeks
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.
BIOLOGICAL4 mg/kg every 8 weeks
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.
BIOLOGICAL8 mg/kg every 8 weeks
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.
BIOLOGICAL12 mg/kg every 8 weeks
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.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* LDL-C must be greater or equal to 130 mg/dl * BMI must be between 18.5 and 40 kg/m2
Exclusion criteria
* History of cardiovascular or cerebrovascular event during the past year. * Poorly controlled type 1 or type 2 diabetes mellitus * Subjects who have taken lipid lowering therapies within the last 3 months of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of anti-drug-antibodies. | Baseline and Day 15 and monthly thereafter |
| Incidence of dose limiting or intolerable treatment related adverse events (AEs). | Every Scheduled Visit |
| Incidence, severity and causal relationship of treatment emergent AEs (TEAEs). | Every Scheduled Visit |
| Incidence of abnormal and clinically relevant safety laboratories. | Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197 |
| Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters. | Every Scheduled Visit |
Secondary
| Measure | Time frame |
|---|---|
| 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. | Day 1 and every scheduled visit thereafter |
| Absolute and percentage change in LDL C from baseline. | Every scheduled visit except Day 1 |
| Proportion of subjects who achieve a target LDL C of <100 mg/mL. | Every scheduled visit except Day 1 |
| Proportion of subjects who achieve a target LDL C of <70 mg/dL. | Every scheduled visit except Day 1 |
| Proportion of subjects achieving 50% decrease in LDL C from baseline. | Every scheduled visit except Day 1 |
Outcome results
None listed