Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

NCT01163838

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia, Dyslipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- LDL-C must be greater or equal to 130 mg/dl

- BMI must be between 18.5 and 40 kg/m2

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Dyslipidemia
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
  • Experimental: RN316: 1 mg/kg every 2 weeks
    Intervention: Biological: 1 mg/kg every 2 weeks
  • Experimental: RN316: 2 mg/kg every 4 weeks
    Intervention: Biological: 2 mg/kg every 4 weeks
  • Experimental: RN316: 4 mg/kg every 4 weeks
    Intervention: Biological: 4 mg/kg every 4 weeks
  • Experimental: RN316: 4 mg/kg every 8 weeks
    Intervention: Biological: 4 mg/kg every 8 weeks
  • Experimental: RN316: 8 mg/kg every 8 weeks
    Intervention: Biological: 8 mg/kg every 8 weeks
  • Experimental: RN316: 12 mg/kg every 8 weeks
    Intervention: Biological: 12 mg/kg every 8 weeks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 21, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2010)
91
Estimated Study Completion Date  ICMJE March 2011
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01163838
Other Study ID Numbers  ICMJE B1481002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP