Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03427710
Recruitment Status : Active, not recruiting
First Posted : February 9, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Civi Biopharma, Inc.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Adaptive design allowing modifications in single and multidose arms
Masking: Single (Participant)
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
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427710


Locations
Layout table for location information
United Kingdom
Leeds Clinic
Leeds, West Yorkshire, United Kingdom, LS2 9LH
Sponsors and Collaborators
Civi Biopharma, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jim Bush, MBChB, PhD Covance

Layout table for additonal information
Responsible Party: Civi Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT03427710     History of Changes
Other Study ID Numbers: CiVi-001
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases