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

CiVi Biopharma

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Other: Placebo; Drug: CiVi007

Study type: Interventional

Funder types: Industry

Identifiers

NCT03427710

CiVi-001

Details and patient eligibility

About

The 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

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 6 patient groups, including a placebo group

Cohort A1

Experimental group

Description:

CiVi007 dose 1

Treatment:

Drug: CiVi007

Cohort A2

Experimental group

Description:

CiVi007 dose 2

Treatment:

Drug: CiVi007

Cohort A3

Experimental group

Description:

CiVi007 dose 3

Treatment:

Drug: CiVi007

Cohort A4

Experimental group

Description:

CiVi007 dose 4

Treatment:

Drug: CiVi007

Cohort A5

Experimental group

Description:

CiVi007 dose 5

Treatment:

Drug: CiVi007

Combined placebo group

Placebo Comparator group

Description:

group response from placebo subsets of dosing cohorts

Treatment:

Other: Placebo