Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

This study has been withdrawn prior to enrollment.
(Study was redesigned based on FDA feedback.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01163838
First received: July 14, 2010
Last updated: September 13, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Dyslipidemia
Biological: Placebo
Biological: 1 mg/kg every 2 weeks
Biological: 2 mg/kg every 4 weeks
Biological: 4 mg/kg every 4 weeks
Biological: 4 mg/kg every 8 weeks
Biological: 8 mg/kg every 8 weeks
Biological: 12 mg/kg every 8 weeks
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of dose limiting or intolerable treatment related adverse events (AEs). [ Time Frame: Every Scheduled Visit ] [ Designated as safety issue: Yes ]
  • Incidence, severity and causal relationship of treatment emergent AEs (TEAEs). [ Time Frame: Every Scheduled Visit ] [ Designated as safety issue: Yes ]
  • Incidence of abnormal and clinically relevant safety laboratories. [ Time Frame: Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197 ] [ Designated as safety issue: Yes ]
  • Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters. [ Time Frame: Every Scheduled Visit ] [ Designated as safety issue: Yes ]
  • Incidence of anti-drug-antibodies. [ Time Frame: Baseline and Day 15 and monthly thereafter ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Absolute and percentage change in LDL C from baseline. [ Time Frame: Every scheduled visit except Day 1 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve a target LDL C of <100 mg/mL. [ Time Frame: Every scheduled visit except Day 1 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve a target LDL C of <70 mg/dL. [ Time Frame: Every scheduled visit except Day 1 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving 50% decrease in LDL C from baseline. [ Time Frame: Every scheduled visit except Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 91
Study Start Date: August 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Biological: Placebo
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.
Experimental: RN316: 1 mg/kg every 2 weeks Biological: 1 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.
Experimental: RN316: 2 mg/kg every 4 weeks Biological: 2 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.
Experimental: RN316: 4 mg/kg every 4 weeks Biological: 4 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.
Experimental: RN316: 4 mg/kg every 8 weeks Biological: 4 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.
Experimental: RN316: 8 mg/kg every 8 weeks Biological: 8 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.
Experimental: RN316: 12 mg/kg every 8 weeks Biological: 12 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163838

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01163838     History of Changes
Other Study ID Numbers: B1481002
Study First Received: July 14, 2010
Last Updated: September 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Hypercholesterolemia
Dyslipidemia
LDL
Cholesterol
High Cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 01, 2014