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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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