A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level
NCT03427710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2020-09-22
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
Interventions
- DRUG
-
CiVi007
cholesterol lowering drug
- OTHER
-
Placebo
matching placebo to CiVi007
Sponsors & Collaborators
-
Civi Biopharma, Inc.
lead INDUSTRY
Principal Investigators
-
Jim Bush, MBChB, PhD · Covance
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-02-07
- Primary Completion
- 2020-02-14
- Completion
- 2020-08-18
Countries
- United Kingdom
Study Locations
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