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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: PRO-040201 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: PRO-040201
PRO-040201 with placebo control in each cohort
 Drug: PRO-040201
Single dose IV infusion
Placebo Comparator: Placebo
PRO-040201 with placebo control in each cohort
 Drug: Placebo
placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of PRO-040201 [ Time Frame: 29 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics of PRO-040201 in Humans [ Time Frame: 48 hours ]
  2. Pharmacodynamics of PRO-040201 in Humans [ Time Frame: 29 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT00927459


Locations
United States, Ohio
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45212
Sponsors and Collaborators
Arbutus Biopharma Corporation
Investigators
Principal Investigator: Douglas Logan, MD Medpace Clinical Pharmacology Unit
More Information
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Responsible Party: Mark Murray, PhD, CEO, Tekmira Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00927459     History of Changes
Other Study ID Numbers: TKM-ApoB-001
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: January 2010

Keywords provided by Arbutus Biopharma Corporation:
cholesterol
coronary artery disease

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