A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Stable Atherothrombotic Disease

In brief

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.

Key facts

Study ID

NCT01499420

Run by

CSL Limited

People needed

45

Starts

2012-02-01

Expected to finish

2013-03-01

Last updated by the study team

2014-02-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study Site — Chula Vista, California, United States
• Study Site — Jacksonville, Florida, United States
• Study Site — Miami, Florida, United States
• Study Site — Lexington, Kentucky, United States
• Study Site — Madisonville, Kentucky, United States
• Study Site — Auburn, Maine, United States
• Study Site — Baltimore, Maryland, United States
• Study Site — Petoskey, Michigan, United States
• Study Site — Durham, North Carolina, United States
• Study Site — Philadelphia, Pennsylvania, United States
• Study Site — Rapid City, South Dakota, United States

Full record on ClinicalTrials.gov

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