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

This study has been terminated.

(Potential for immune stimulation to interfere with further dose escalation.)

Sponsor:

Information provided by:

Arbutus Biopharma Corporation

ClinicalTrials.gov Identifier:

NCT00927459

First received: June 23, 2009

Last updated: January 21, 2010

Last verified: January 2010

History of Changes

Purpose

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	Intervention	Phase
Hypercholesterolemia	Drug: PRO-040201 Drug: Placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

Further study details as provided by Arbutus Biopharma Corporation:

Primary Outcome Measures:

Safety and tolerability of PRO-040201 [ Time Frame: 29 days ]

Secondary Outcome Measures:

Pharmacokinetics of PRO-040201 in Humans [ Time Frame: 48 hours ]
Pharmacodynamics of PRO-040201 in Humans [ Time Frame: 29 days ]


Enrollment:	23
Study Start Date:	June 2009
Study Completion Date:	January 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Mark Murray, PhD, CEO, Tekmira Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:	NCT00927459 History of Changes
Other Study ID Numbers:	TKM-ApoB-001
Study First Received:	June 23, 2009
Last Updated:	January 21, 2010

Keywords provided by Arbutus Biopharma Corporation:


cholesterol coronary artery disease

Additional relevant MeSH terms:


Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on June 22, 2017

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