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

NCT ID: NCT03427710

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-07
• Study Completion Date: 2020-08-18

Brief Summary

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

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort A1

CiVi007 dose 1

Group Type: EXPERIMENTAL

CiVi007

Intervention Type: DRUG

cholesterol lowering drug

Cohort A2

CiVi007 dose 2

Group Type: EXPERIMENTAL

CiVi007

Intervention Type: DRUG

cholesterol lowering drug

Cohort A3

CiVi007 dose 3

Group Type: EXPERIMENTAL

CiVi007

Intervention Type: DRUG

cholesterol lowering drug

Cohort A4

CiVi007 dose 4

Group Type: EXPERIMENTAL

CiVi007

Intervention Type: DRUG

cholesterol lowering drug

Cohort A5

CiVi007 dose 5

Group Type: EXPERIMENTAL

CiVi007

Intervention Type: DRUG

cholesterol lowering drug

Combined placebo group

group response from placebo subsets of dosing cohorts

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

matching placebo to CiVi007

Interventions

CiVi007

cholesterol lowering drug

Intervention Type: DRUG

Placebo

matching placebo to CiVi007

Intervention Type: OTHER

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Civi Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jim Bush, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Covance

Locations

Leeds Clinic

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

CiVi-001

Identifier Type: -

Identifier Source: org_study_id