Status:
COMPLETED
A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level
Lead Sponsor:
Civi Biopharma, Inc.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03427710
Start Date
February 7 2018
End Date
August 18 2020
Last Update
September 22 2020
Active Locations (1)
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1
Leeds Clinic
Leeds, West Yorkshire, United Kingdom, LS2 9LH