Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

Phase 1

Withdrawn

• Conditions: Hypercholesterolemia; Dyslipidemia
• Interventions: Biological: 1 mg/kg every 2 weeks; Biological: 2 mg/kg every 4 weeks; Biological: 4 mg/kg every 4 weeks; Biological: 8 mg/kg every 8 weeks; Biological: 12 mg/kg every 8 weeks; Biological: Placebo; Biological: 4 mg/kg every 8 weeks

• Registration Number: NCT01163838
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Study Start: 2010-08
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RN316: 1 mg/kg every 2 weeks	1 mg/kg every 2 weeks	-
RN316: 2 mg/kg every 4 weeks	2 mg/kg every 4 weeks	-
RN316: 4 mg/kg every 4 weeks	4 mg/kg every 4 weeks	-
RN316: 8 mg/kg every 8 weeks	8 mg/kg every 8 weeks	-
RN316: 12 mg/kg every 8 weeks	12 mg/kg every 8 weeks	-
Placebo	Placebo	-
RN316: 4 mg/kg every 8 weeks	4 mg/kg every 8 weeks	-

Primary Outcome Measures

Name	Time	Method
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
Incidence of anti-drug-antibodies.	Baseline and Day 15 and monthly thereafter

Secondary Outcome Measures

Name	Time	Method
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