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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427710
• Other study ID #: CiVi-001
• Status: Completed
• Phase: Phase 1
• Start date: February 7, 2018
• Est. completion date: August 18, 2020

Study information

• Verified date: September 2020
• Source: Civi Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 18, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• CiVi007
cholesterol lowering drug

Other:
• Placebo
matching placebo to CiVi007

Locations

Country	Name	City	State
United Kingdom	Leeds Clinic	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Civi Biopharma, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL Cholesterol	% LDL-C reduction	Maximum post dose within 8 weeks
Secondary	Peak Plasma Concentration (Cmax) of CiVi007	Pharmacokinetic Outcome Measure	8 weeks
Secondary	PCSK9 level	maximal % reduction in the level of circulating PCSK9	Maximum post dose within 8 weeks