Title
A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level
A Placebo-controlled, Single Blind, Randomised, Phase I, First In Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered CiVi007 in Subjects With an Elevated LDL C Level
Phase
Phase 1Lead Sponsor
Civi Biopharma, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HypercholesterolemiaIntervention/Treatment
CiVi007 ...Study Participants
36The primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of CiVi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy
cholesterol lowering drug
matching placebo to CiVi007
group response from placebo subsets of dosing cohorts
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.
