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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01163838
First Posted: July 16, 2010
Last Update Posted: April 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • 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 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 ]
  • 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. [ Time Frame: Every scheduled visit except Day 1 ]

Enrollment: 0
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163838


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01163838     History of Changes
Other Study ID Numbers: B1481002
First Submitted: July 14, 2010
First Posted: July 16, 2010
Last Update Posted: April 23, 2015
Last Verified: April 2015

Keywords provided by Pfizer:
Hypercholesterolemia
Dyslipidemia
LDL
Cholesterol
High Cholesterol

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