CiVi007- Phase 1 safety tolerability PK PD study
Research type
Research Study
Full 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
IRAS ID
233253
Contact name
Jim Bush
Contact email
Sponsor organisation
CiVi Biopharma
Eudract number
2017-004204-22
Duration of Study in the UK
1 years, 4 months, 2 days
Research summary
The study drug (CiVi007) is an investigational drug which has been developed as a potential treatment for high cholesterol levels and to help people with atherosclerotic cardiovascular disease (ASCVD).
ASCVD develops due to high levels of a type of cholesterol called low-density lipoprotein cholesterol (LDL-C) being present in the blood. This cholesterol can build-up as fatty deposits on the inner walls of the arteries making them harder and narrower, leading to reduced blood flow which can result in a heart attack or a stroke.
Current treatments for ASCVD include statins which help to prevent the disease by lowering the levels of cholesterol in the blood by reducing the production of cholesterol in the liver. However, for some people statins are limited in how much they can lower the blood cholesterol levels without having too many side effects.
The study drug works in a different way to statins with the hope of achieving more significant lowering of blood cholesterol levels. The study drug is developed to be used on its own or in combination with existing therapies such as statins to help prevent ASCVD.
This Study is the first time that the study drug is being given to humans. It has been tested extensively in animals at doses higher than the highest dose planned for this Study with no serious adverse effects.
Up to 68 participants will be participating in this study (up to 20 in Part A and up to 48 in Part B).
Participants in Part A will receive a single subcutaneous (in the fatty layer beneath the skin) injection of the study drug/ placebo while participants in Part B will receive 2 injections of the study drug/ placebo.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0420
Date of REC Opinion
22 Dec 2017
REC opinion
Further Information Favourable Opinion