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

NCT03427710 | Completed Phase 1

• 1 other identifier: CiVi-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• LDL Cholesterol

  % LDL-C reduction

  Maximum post dose within 8 weeks

Secondary Outcomes (2)

• Peak Plasma Concentration (Cmax) of CiVi007

  8 weeks

• PCSK9 level

  Maximum post dose within 8 weeks

Study Arms (6)

Cohort A1

EXPERIMENTAL

CiVi007 dose 1

Drug: CiVi007

Cohort A2

EXPERIMENTAL

CiVi007 dose 2

Drug: CiVi007

Cohort A3

EXPERIMENTAL

CiVi007 dose 3

Drug: CiVi007

Cohort A4

EXPERIMENTAL

CiVi007 dose 4

Drug: CiVi007

Cohort A5

EXPERIMENTAL

CiVi007 dose 5

Drug: CiVi007

Combined placebo group

PLACEBO COMPARATOR

group response from placebo subsets of dosing cohorts

Other: Placebo

Interventions

CiVi007 DRUG

cholesterol lowering drug

Cohort A1; Cohort A2; Cohort A3; Cohort A4; Cohort A5

Placebo OTHER

matching placebo to CiVi007

Combined placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Civi Biopharma, Inc.: lead

Study Sites (1)

Leeds Clinic

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jim Bush, MBChB, PhD

  Covance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Adaptive design allowing modifications in single and multidose arms

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 9, 2018
• Study Start: February 7, 2018
• Primary Completion: February 14, 2020
• Study Completion: August 18, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

GB (1)