A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level

This is an interventional treatment trial for Hypercholesterolemia Read More

Key Inclusion Criteria:

• Males or females, of any race, with fasting LDL C >2.6 mmol/L (100 mg/dL) and fasting serum triglycerides <4.52 mmol/L (400 mg/dL)
• haematology and clinical chemistry without clinically significant abnormal values
• Normal renal and hepatic function
• Women must not be pregnant, lactating or of child bearing potential
• Men must be willing to use appropriate contraception during the study
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Key Exclusion Criteria:

• Any uncontrolled or serious disease, or any medical or surgical condition
• History or presence of coronary heart disease, peripheral artery disease, or cerebrovascular disease
• Uncontrolled hypertension
• Insulin dependent diabetes mellitus
• Secondary dyslipidemia
• History of renal or hepatic diseases, acquired immune deficiency syndrome, positive human immunodeficiency virus test and/or history of viral hepatitis B or C
• History of cancer within 5 years
• History of high alcohol consumption or positive alcohol breath test or urinary test for drugs of abuse
• Participation in another clinical study within 3 months prior to screening or participation in another study
• Use of treatment (e.g. antibody) towards PCSK9
• History of multiple drug allergies or intolerance to subcutaneous injection.