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

January 21, 2010 updated by: Arbutus Biopharma Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Medpace Clinical Pharmacology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of PRO-040201
Time Frame: 29 days
29 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of PRO-040201 in Humans
Time Frame: 48 hours
48 hours
Pharmacodynamics of PRO-040201 in Humans
Time Frame: 29 days
29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbutus Biopharma Corporation

Investigators

  • Principal Investigator: Douglas Logan, MD, Medpace Clinical Pharmacology Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Estimate)

January 22, 2010

Last Update Submitted That Met QC Criteria

January 21, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKM-ApoB-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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