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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia | Drug: PRO-040201 Drug: Placebo | Phase 1 |
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 |
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
|
- Safety and tolerability of PRO-040201 [ Time Frame: 29 days ]
- Pharmacokinetics of PRO-040201 in Humans [ Time Frame: 48 hours ]
- Pharmacodynamics of PRO-040201 in Humans [ Time Frame: 29 days ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Ohio | |
Medpace Clinical Pharmacology Unit | |
Cincinnati, Ohio, United States, 45212 |
Principal Investigator: | Douglas Logan, MD | Medpace Clinical Pharmacology Unit |
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 |