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Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol

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.
 
ClinicalTrials.gov Identifier: NCT00927459
Recruitment Status : Terminated (Potential for immune stimulation to interfere with further dose escalation.)
First Posted : June 25, 2009
Last Update Posted : January 22, 2010
Sponsor:
Information provided by:
Arbutus Biopharma Corporation

Tracking Information
First Submitted Date  ICMJE June 23, 2009
First Posted Date  ICMJE June 25, 2009
Last Update Posted Date January 22, 2010
Study Start Date  ICMJE June 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
Safety and tolerability of PRO-040201 [ Time Frame: 29 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
  • Pharmacokinetics of PRO-040201 in Humans [ Time Frame: 48 hours ]
  • Pharmacodynamics of PRO-040201 in Humans [ Time Frame: 29 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol
Official Title  ICMJE A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO-040201 in Male and Female Subjects With Hypercholesterolemia
Brief Summary This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study in male and female subjects with high cholesterol. A maximum of 32 subjects is planned for enrollment in this study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: PRO-040201
    Single dose IV infusion
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Experimental: PRO-040201
    PRO-040201 with placebo control in each cohort
    Intervention: Drug: PRO-040201
  • Placebo Comparator: Placebo
    PRO-040201 with placebo control in each cohort
    Intervention: Drug: Placebo
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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 21, 2010)
23
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2009)
32
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fasting, stable LDL-C ≥ 160 mg/dL
  • Fasting, stable triglyceride < 400 mg/dL
  • BMI between 22 and 35 kg/m2, inclusive
  • Females must be of non-child bearing potential
  • Males of reproductive potential must agree to practice effective contraception throughout the study and for 3 months following infusion

Exclusion Criteria:

  • Clinically significant endocrine, hematologic, renal, hepatic, pulmonary, uncontrolled psychiatric, or neurologic disease
  • Cancer within 5 years prior to screening
  • History of congestive heart failure or chronic heart failure
  • Uncontrolled cardiac arrhythmias
  • History of coronary heart disease
  • Clinically significant abnormal baseline ECG
  • History of additional risk factors for torsades de pointes
  • Hepatitis B, C, or HIV positive
  • Current diagnosis or known history of liver disease
  • A marked baseline prolongation of QT/QTc interval
  • Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or a creatine phosphokinase (CPK) >3 x upper limit of normal (ULN) at screening
  • Alanine aminotransferase, AST, GGT, or total bilirubin >2 x ULN at screening
  • Serum creatinine > 1.5 mg/dL
  • Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on 2 occasions during screening
  • Concomitant use of medications that prolongs the QT/QTc interval
  • Treatment with lipid lowering therapy within 30 days prior to screening
  • Use of investigational drug within 3 months prior to screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00927459
Other Study ID Numbers  ICMJE TKM-ApoB-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Murray, PhD, CEO, Tekmira Pharmaceuticals Corporation
Study Sponsor  ICMJE Arbutus Biopharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas Logan, MD Medpace Clinical Pharmacology Unit
PRS Account Arbutus Biopharma Corporation
Verification Date January 2010

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