NCT01499420
Completed
Phase 2
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
ConditionsStable Atherothrombotic Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stable Atherothrombotic Disease
- Sponsor
- CSL Limited
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Safety
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Safety
Time Frame: 14 days
The frequency of study product-related adverse events
Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
Time Frame: 14 days
Number of subjects with clinically significant elevation of ALT or AST
Secondary Outcomes
- Pharmacokinetic profile of apolipoprotein A-I (apoA-I)(9 days)
- Plasma apoA-I area under the curve (AUC)(9 days)
- Plasma apoA-I Cmax(9 days)
- Plasma apoA-I Tmax(9 days)
Study Sites (1)
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