Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol

The SAD part will consist of up to 8 cohorts of eligible participants with elevated LDL-C as defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive)

The MAD part will consist of up to 8 cohorts of eligible participants with elevated LDL-C as defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive)

Inclusion criteria

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• Male or female, ≥18 and ≤65 years of age, with BMI ≥18.5 and ≤35.0 kg/m2.
• Participants must be either non smoking (no use of tobacco or nicotine products within 3 months prior to screening) or social smoker as defined by smoking no more than 5 cigarettes (or nicotine equivalent) a week and no smoking during screening period or on study.
• Participants must be with elevated LDL-C defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive) at screening.
• Healthy (except for the LDL-C status) participants.
• Participants must have fasting triglyceride level <4.52 mmol/L (<400mg/dL) at screening.
• Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study as detailed in section 8.1.
• Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion criteria

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• Any clinically significant abnormal finding at physical examination in the opinion of the investigator.
• Subjects with a history or presence of cardiovascular disease (including cerebrovascular accident (stroke or TIA) or disease, uncontrolled hypertension, familial hypercholesterolaemia, obstructive sleep apnoea, and peripheral artery), a diagnosis of diabetes mellitus given potential for hyperglycaemia defined as HbA1c greater or equal to 6.5%, or a non-alcoholic fatty liver disease.
• Received Leqvio (inclisiran) treatment in less than 6 months ago.
• Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.