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Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

Primary Purpose

Hypercholesterolemia, Dyslipidemia

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
1 mg/kg every 2 weeks
2 mg/kg every 4 weeks
4 mg/kg every 4 weeks
4 mg/kg every 8 weeks
8 mg/kg every 8 weeks
12 mg/kg every 8 weeks
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia, Dyslipidemia, LDL, Cholesterol, High Cholesterol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    RN316: 1 mg/kg every 2 weeks

    RN316: 2 mg/kg every 4 weeks

    RN316: 4 mg/kg every 4 weeks

    RN316: 4 mg/kg every 8 weeks

    RN316: 8 mg/kg every 8 weeks

    RN316: 12 mg/kg every 8 weeks

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence of dose limiting or intolerable treatment related adverse events (AEs).
    Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
    Incidence of abnormal and clinically relevant safety laboratories.
    Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
    Incidence of anti-drug-antibodies.

    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.
    Absolute and percentage change in LDL C from baseline.
    Proportion of subjects who achieve a target LDL C of <100 mg/mL.
    Proportion of subjects who achieve a target LDL C of <70 mg/dL.
    Proportion of subjects achieving 50% decrease in LDL C from baseline.

    Full Information

    First Posted
    July 14, 2010
    Last Updated
    April 21, 2015
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01163838
    Brief Title
    Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was redesigned based on FDA feedback.
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    March 2011 (Anticipated)
    Study Completion Date
    March 2011 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Dyslipidemia
    Keywords
    Hypercholesterolemia, Dyslipidemia, LDL, Cholesterol, High Cholesterol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    RN316: 1 mg/kg every 2 weeks
    Arm Type
    Experimental
    Arm Title
    RN316: 2 mg/kg every 4 weeks
    Arm Type
    Experimental
    Arm Title
    RN316: 4 mg/kg every 4 weeks
    Arm Type
    Experimental
    Arm Title
    RN316: 4 mg/kg every 8 weeks
    Arm Type
    Experimental
    Arm Title
    RN316: 8 mg/kg every 8 weeks
    Arm Type
    Experimental
    Arm Title
    RN316: 12 mg/kg every 8 weeks
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    1 mg/kg every 2 weeks
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    2 mg/kg every 4 weeks
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    4 mg/kg every 4 weeks
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    4 mg/kg every 8 weeks
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    8 mg/kg every 8 weeks
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    12 mg/kg every 8 weeks
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of dose limiting or intolerable treatment related adverse events (AEs).
    Time Frame
    Every Scheduled Visit
    Title
    Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
    Time Frame
    Every Scheduled Visit
    Title
    Incidence of abnormal and clinically relevant safety laboratories.
    Time Frame
    Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197
    Title
    Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
    Time Frame
    Every Scheduled Visit
    Title
    Incidence of anti-drug-antibodies.
    Time Frame
    Baseline and Day 15 and monthly thereafter
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Absolute and percentage change in LDL C from baseline.
    Time Frame
    Every scheduled visit except Day 1
    Title
    Proportion of subjects who achieve a target LDL C of <100 mg/mL.
    Time Frame
    Every scheduled visit except Day 1
    Title
    Proportion of subjects who achieve a target LDL C of <70 mg/dL.
    Time Frame
    Every scheduled visit except Day 1
    Title
    Proportion of subjects achieving 50% decrease in LDL C from baseline.
    Time Frame
    Every scheduled visit except Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481002&StudyName=Multiple-Dose%20Safety%20Study%20Of%20RN316%20For%20TheTreatment%20Of%20Hypercholesterolemia
    Description
    To obtain contact information for a study center near you, click here.

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