A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients
This study has been completed.
Sponsor:
CSL Limited
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT01499420
First received: December 19, 2011
Last updated: April 17, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stable Atherothrombotic Disease |
Biological: CSL112 (reconstituted high density lipoprotein) Biological: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | 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 |
Further study details as provided by CSL Limited:
Primary Outcome Measures:
- Safety [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]The frequency of study product-related adverse events
- Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]Number of subjects with clinically significant elevation of ALT or AST
Secondary Outcome Measures:
- Pharmacokinetic profile of apolipoprotein A-I (apoA-I) [ Time Frame: 9 days ] [ Designated as safety issue: No ]Plasma apoA-I concentration with and without baseline correction
- Plasma apoA-I area under the curve (AUC) [ Time Frame: 9 days ] [ Designated as safety issue: No ]
- Plasma apoA-I Cmax [ Time Frame: 9 days ] [ Designated as safety issue: No ]
- Plasma apoA-I Tmax [ Time Frame: 9 days ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | February 2012 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CSL112 |
Biological: CSL112 (reconstituted high density lipoprotein)
Single escalating intravenous doses of CSL112
|
| Placebo Comparator: Placebo |
Biological: Placebo
Single intravenous doses of normal saline (0.9%)
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499420
Locations
| United States, California | |
| Study Site | |
| Chula Vista, California, United States, 91911 | |
| United States, Florida | |
| Study Site | |
| Jacksonville, Florida, United States, 32209 | |
| Study Site | |
| Miami, Florida, United States, 33126 | |
| United States, Kentucky | |
| Study Site | |
| Lexington, Kentucky, United States, 40536 | |
| Study Site | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Maine | |
| Study Site | |
| Auburn, Maine, United States, 04210 | |
| United States, Maryland | |
| Study Site | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Michigan | |
| Study Site | |
| Petoskey, Michigan, United States, 49770 | |
| United States, North Carolina | |
| Study Site | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Study Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Dakota | |
| Study Site | |
| Rapid City, South Dakota, United States, 57701 | |
Sponsors and Collaborators
CSL Limited
Investigators
| Study Director: | Dr. Denise D'Andrea | CSL Limited |
More Information
No publications provided
| Responsible Party: | CSL Limited |
| ClinicalTrials.gov Identifier: | NCT01499420 History of Changes |
| Other Study ID Numbers: | CSLCT-HDL-10-70a |
| Study First Received: | December 19, 2011 |
| Last Updated: | April 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 19, 2013