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A Study to Evaluate COR-1004 in Adult Volunteers.

RecruitingPhase 1Ages 18 Years - 65 YearsAllCorsera Health
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In plain words

What the trial is, and whether it could suit you

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 sho

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Serum LDL-C โ‰ฅ100 mg/dL (โ‰ฅ2.6 mmol/L) at Screening. * Female participants who are of childbearing potential must be willing to use two highly effective methods of contraception, one of which should be a barrier method. * Post-menopausal females must be post-menopausal for 12 months. * Male participants and their partners of child-bearing potential must be willing to use two highly effective methods of contraception, one of which must be a barrier method (e.g., condom) through the end of the study (Day 360). Male participants and their same-sex partners must use a barrier method of contraception. Male participants must be willing not to donate sperm until the end of the study. Male participants who had vasectomy must provide the date of the procedure. * Able to participate, and willing to give written informed consent and to comply with the study restrictions. Exclusion Criteria: * Any active or chronic disease. * Active or history of serious mental illness or psychiatric disorder. * Clinically significant illness within seven days before study drug administration. * Having risk of atherosclerotic cardiovascular disease (ASCVD) โ‰ฅ7.5% based on the ASCVD Risk Estimator Plus. * Having fasting triglyceride level โ‰ฅ400 mg/dL (โ‰ฅ4.52 mmol/L). * Clinically significant abnormalities on physical examination, vital signs, or laboratory test results (except for serum LDL-C) during Screening or prior to admission to the study unit. * Participants with any risk factors or family history for QT or Fridericia-corrected QT interval (QTcF) prolongation or ECG abnormalities or any abnormality in the ECG. * Confirmed systolic blood pressure (SBP) \>140 mmHg or diastolic blood pressure (DBP) \>90 mmHg at Screening, Day -1, or pre-dose. * Mean resting pulse rate \<40 bpm or \>90 bpm at Screening. * Abnormal renal function including serum creatinine greater than the upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) \<60 mL/min (using the Cockcroft-Gault formula). * Alanine aminotransferase (ALT) and/or total bilirubin above the ULN. Aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma glutamyl transferase (GGT) \>2 ร— ULN. International normalized ratio (INR) above the upper bound of the normal reference range (as per the local laboratory reference range) at Screening. * Positive hepatitis B surface antigen, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection. * Pregnant or lactating women, or males with female partners who are pregnant or lactating. * History of multiple drug allergies or history of allergic reaction to an oligonucleotide, N-acetylgalactosamine (GalNAc), or inclisiran. * Participation in an investigational drug or device study within 45 days or five half-lives (whichever time period is longer) or six months for biologic therapies prior to study drug administration. * Received small interfering ribonucleic acid (siRNA) as an investigational or approved product prior to study drug administration. * Use of any medications (prescription or over-the-counter) or herbal supplements within two weeks or five half-lives (whichever is longer) prior to study drug administration (six months for biologic therapies), with exception of acetaminophen/paracetamol up to 2 g per day up to 48 hours prior to dosing or medications for contraception. Other exceptions will only be made if the rationale is discussed and clearly documented between the Clinical Research Organization and Sponsor. * Received any medication, herbal supplements, or nutraceutical known to alter serum lipids within 30 days before Screening (eg, niacin).
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What it tests

  • COR-1004
  • Placebo
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Where

2 sites
Clinical Trial Site 1
Christchurch, New Zealand
Clinical Trial Site 2
Wellington, New Zealand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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