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

CSL Limited

Status and phase

Completed

Phase 2

Conditions

Stable Atherothrombotic Disease

Treatments

Biological: Placebo

Biological: CSL112 (reconstituted high density lipoprotein)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01499420

CSLCT-HDL-10-70a

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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