A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of RN316 In Healthy Adult Subjects With Hypercholesterolemia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypercholesterolemia
- Sponsor
- Pfizer
- Primary Endpoint
- Incidence of dose limiting or intolerable treatment related adverse events (AEs).
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)