Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study in Patients With Coronary Heart Disease (CHD) to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of APL180

The design of this study will enable an extensive evaluation of safety, tolerability, and PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease

Inclusion Criteria:

• Male and female CHD or CHD equivalent patients
• Body mass index (BMI) must be within the range of 20 to 35 kg/m2,
• Patient must have been on a stable statin therapy for >8 weeks prior to first dose except for the statin intolerant patients.

Exclusion criteria:

• Pregnancy
• Significant illness within two weeks prior to dosing.
• Triglycerides ≥ 500 mg/dl (5.65 mmol/l)
• Uncontrolled hypertension
• Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
• Presence of NYHA Class III or IV chronic heart failure
• MI or angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to do Other protocol-defined inclusion/exclusion criteria may apply