A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Limited
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients
