- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01499420
A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients
January 8, 2014 updated by: CSL Limited
A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of CSL112 in Patients With Stable Atherothrombotic Disease
Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events.
This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
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
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California
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Chula Vista, California, United States, 91911
- Study Site
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Florida
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Jacksonville, Florida, United States, 32209
- Study Site
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Miami, Florida, United States, 33126
- Study Site
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Kentucky
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Lexington, Kentucky, United States, 40536
- Study Site
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Madisonville, Kentucky, United States, 42431
- Study Site
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Maine
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Auburn, Maine, United States, 04210
- Study Site
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Maryland
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Baltimore, Maryland, United States, 21215
- Study Site
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Michigan
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Petoskey, Michigan, United States, 49770
- Study Site
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North Carolina
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Durham, North Carolina, United States, 27710
- Study Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Study Site
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Study Site
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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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female aged 18 years to 80 years.
- Subjects must have documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization.
- Subjects on a stable medication regimen.
- Body weight 50 kg or greater at screening.
Exclusion Criteria:
- Moderate/severe heart failure or renal impairment.
- Uncontrolled hyperglycemia in subjects with type 1 or type 2 diabetes.
- Receipt of the combination of omeprazole and clopidogrel within 1 month of randomization.
- Subjects whose medical history, condition or medication regimen may interfere with the evaluation of the safety and tolerability of CSL112 (for example significantly altered electrocardiogram (ECG) waveform, hepatobiliary disease, malignancy, thrombocytopenia, etc.)
- Known hypersensitivity to the product components
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Single intravenous doses of normal saline (0.9%)
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Experimental: CSL112
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Single escalating intravenous doses of CSL112
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 14 days
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The frequency of study product-related adverse events
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14 days
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Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
Time Frame: 14 days
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Number of subjects with clinically significant elevation of ALT or AST
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14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic profile of apolipoprotein A-I (apoA-I)
Time Frame: 9 days
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Plasma apoA-I concentration with and without baseline correction
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9 days
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Plasma apoA-I area under the curve (AUC)
Time Frame: 9 days
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9 days
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Plasma apoA-I Cmax
Time Frame: 9 days
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9 days
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Plasma apoA-I Tmax
Time Frame: 9 days
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9 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dr. Denise D'Andrea, CSL Limited
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.
- Tricoci P, D'Andrea DM, Gurbel PA, Yao Z, Cuchel M, Winston B, Schott R, Weiss R, Blazing MA, Cannon L, Bailey A, Angiolillo DJ, Gille A, Shear CL, Wright SD, Alexander JH. Infusion of Reconstituted High-Density Lipoprotein, CSL112, in Patients With Atherosclerosis: Safety and Pharmacokinetic Results From a Phase 2a Randomized Clinical Trial. J Am Heart Assoc. 2015 Aug 25;4(8):e002171. doi: 10.1161/JAHA.115.002171.
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
February 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
December 19, 2011
First Submitted That Met QC Criteria
December 22, 2011
First Posted (Estimate)
December 26, 2011
Study Record Updates
Last Update Posted (Estimate)
February 6, 2014
Last Update Submitted That Met QC Criteria
January 8, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- CSLCT-HDL-10-70a
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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