Actively Recruiting
A Study to Evaluate COR-1004 in Adult Volunteers.
Led by Corsera Health · Updated on 2026-01-28
60
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study is being done to see if a new, injectable drug called COR-1004 is safe for people to take. It will also help doctors find the right dose of the drug. The study will look at how different dose levels of COR-1004 affect the levels of LDL cholesterol (often called "bad" cholesterol) in the blood. The study will enroll otherwise healthy volunteers who have LDL cholesterol of 100 mg/dl or higher but are not currently taking any cholesterol-lowering medicines. The main purpose of this study is to test a new drug, COR-1004. Researchers want to find out: * If the drug is safe and if people have any side effects. * The highest dose that can be given without causing serious side effects. * How the body processes the drug. * How the drug affects the amount of "bad" cholesterol in the blood. This is an early-phase study. The information learned will help decide if COR-1004 should be tested in larger studies in the future. To be in this study, you must: * Be generally healthy. * Have an LDL ("bad") cholesterol level of 100 mg/dL or higher. * Not currently be taking any medications to lower your cholesterol. If you decide to join the study, you will be placed into a group by chance, like flipping a coin. This is called "randomization." In each group, most people (8 out of 10) will get a single injection of the study drug (COR-1004). The other people (2 out of 10) will get a placebo. A placebo looks just like the study drug but has no active medicine in it. Using a placebo helps researchers understand the true effects of the real drug. This is a "double-blind" study, which means that neither you nor the study doctor will know if you are getting the study drug or the placebo. The study will test different dose levels of COR-1004. It will start with a low dose and, only if it is proven to be safe, will a new group of participants be given a slightly higher dose. To be extra safe, the first two people in each new dose group will be watched for 24 hours before the other eight people in that group get their injection. After the injection, you will need to visit the study clinic several times over the next year for follow-up. These visits will include: * Answering questions about your health. * Physical exams. * Blood tests to check your safety and your cholesterol levels. A special group of experts, called a Safety Review Committee, will carefully watch over the study to protect all participants. Your active participation in the study, including follow-up visits, will last for about 12 months after you receive the single injection. Because COR-1004 is a new drug, there may be risks that are not yet known. The study staff will explain all the known risks to you before you agree to participate. Known risks may include discomfort at the injection site, like redness, swelling, or pain. The study team will monitor you very closely for any side effects throughout the study.
CONDITIONS
Official Title
A Study to Evaluate COR-1004 in Adult Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Serum LDL-C �3E=100 mg/dL at screening.
- Female participants of childbearing potential must agree to use two effective contraception methods, including a barrier method.
- Post-menopausal females must be at least 12 months post-menopause.
- Male participants and their partners of childbearing potential must agree to use two effective contraception methods, including a barrier method, for 90 days after dosing.
- Able and willing to provide informed consent and follow study rules.
You will not qualify if you...
- Any active or chronic disease.
- History or presence of serious mental illness or psychiatric disorder.
- Significant illness within 7 days before dosing.
- Risk of atherosclerotic cardiovascular disease (ASCVD) 7.5% or higher.
- Fasting triglycerides 400 mg/dL or higher.
- Significant abnormalities in physical exam, vital signs, or labs (except LDL-C) during screening.
- Risk factors or history of QT interval prolongation or ECG abnormalities.
- High blood pressure (systolic >140 mmHg or diastolic >90 mmHg) at screening or before dosing.
- Resting pulse rate below 40 bpm or above 90 bpm at screening.
- Abnormal kidney function (serum creatinine above normal or creatinine clearance below 60 mL/min).
- Elevated liver enzymes or abnormal clotting test results.
- Positive tests for hepatitis B, hepatitis C, or HIV.
- Pregnant or breastfeeding women or males with pregnant or breastfeeding partners.
- History of multiple drug allergies or allergic reactions to related substances.
- Participation in another investigational study too recently.
- Prior treatment with siRNA products.
- Use of medications or supplements affecting lipids within 30 days before screening, except certain allowed medications.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinical Trial Site
Christchurch, New Zealand, 6011
Actively Recruiting
Research Team
C
Corsera Clinical Trial Information Line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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