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

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arbutus Biopharma Corporation

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