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

• ClinicalTrials.gov Identifier: NCT03427710
• Recruitment Status: Completed
• First Posted: February 9, 2018
• Last Update Posted: September 22, 2020
• Sponsor: Civi Biopharma, Inc.
• Information provided by (Responsible Party): Civi Biopharma, Inc.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: CiVi007; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Adaptive design allowing modifications in single and multidose arms
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 7, 2018
• Actual Primary Completion Date: February 14, 2020
• Actual Study Completion Date: August 18, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort A1; CiVi007 dose 1	Drug: CiVi007; cholesterol lowering drug
Experimental: Cohort A2; CiVi007 dose 2	Drug: CiVi007; cholesterol lowering drug
Experimental: Cohort A3; CiVi007 dose 3	Drug: CiVi007; cholesterol lowering drug
Experimental: Cohort A4; CiVi007 dose 4	Drug: CiVi007; cholesterol lowering drug
Experimental: Cohort A5; CiVi007 dose 5	Drug: CiVi007; cholesterol lowering drug
Placebo Comparator: Combined placebo group; group response from placebo subsets of dosing cohorts	Other: Placebo; matching placebo to CiVi007

Outcome Measures

Primary Outcome Measures :

1. LDL Cholesterol [ Time Frame: Maximum post dose within 8 weeks ]
   % LDL-C reduction

Secondary Outcome Measures :

1. Peak Plasma Concentration (Cmax) of CiVi007 [ Time Frame: 8 weeks ]
   Pharmacokinetic Outcome Measure
2. PCSK9 level [ Time Frame: Maximum post dose within 8 weeks ]
   maximal % reduction in the level of circulating PCSK9

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United Kingdom

Leeds Clinic

Leeds, West Yorkshire, United Kingdom, LS2 9LH

Sponsors and Collaborators

Civi Biopharma, Inc.

Investigators

• Principal Investigator: Jim Bush, MBChB, PhD; Covance

More Information

• Responsible Party: Civi Biopharma, Inc.
• ClinicalTrials.gov Identifier: NCT03427710
• Other Study ID Numbers: CiVi-001
• First Posted: February 9, 2018
• Last Update Posted: September 22, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases