Important Information
If you are interested in applying for this study, please:
- read the study description and study information document
- review the Visit Planner dates in your location and confirm that you are available for the stated dates.
- If you have not yet registered with us, click on the ‘Register’ button at the top of this page and answer the questions.
- If you have already registered with us, answer the pre-screening questions listed below and submit your interest.
We will then contact you to check your suitability.
Study Information
New Zealand Clinical Research is trialling an investigational medicine that could help prevent cardiovascular disease.
The investigational medicine, COR-1004, is being developed to help reduce the level of “bad” cholesterol (LDL cholesterol) in the blood. High levels of cholesterol can increase your risk of diseases such as coronary heart disease (which can lead to heart attacks) by narrowing or blocking your blood vessels with a build-up of cholesterol in your blood. Approximately 1 in 4 New Zealanders need to manage their cholesterol levels.
COR-1004 is an investigational medication designed to block a protein in your body called PCSK9. High levels of PCSK9 are harmful because they prevent your body from clearing “bad cholesterol”. If we block PCSK9, your body is more effective in clearing “bad cholesterol” and this may lower your risk of a heart attack or stroke in the future.
COR-1004 is investigational, which means that it is not approved for general use by Medsafe. Investigational medicines must be tested in studies like this one before they can be approved for use.
This study will also investigate LEQVIO® (inclisiran), which is a medication used for the treatment of high LDL cholesterol. This medication is approved for use in New Zealand by Medsafe.
The purpose of this study is to assess:
- How safe and tolerable a single dose of COR-1004 is, in healthy people
- How a single dose of COR-1004 is processed and cleared by the body
- How the body responds to a single dose of COR-1004
- How the body responds to a single dose of LEQVIO® (inclisiran)
This is a first-in-human study, and we are looking for healthy volunteers to support the research.
This study HDEC FULL 23991 is being funded by Corsera Health, Inc., and has been approved by the Health and Disability Ethics Committee.
Requirements
- Male or Female
- Aged between 18 – 65 years
- BMI (Body Mass Index) between 18 – 35 kg/m2
- No regular medications (eg. antidepressants)
- No smokers or vapers
What is Involved?
- Study Visits: 3 night stay + 14 clinic visits
- Payment: $7,000 before tax