Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT07229118
Eligibility Criteria:
Inclusion Criteria:
* Serum LDL-C ≥100 mg/dL (≥2.6 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, or same-sex partners, must be willing to use two highly effective methods of contraception, one of which must be a barrier method (eg, condom) for 90 days after study drug administration.
* 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) ≥7.5% based on the ASCVD Risk Estimator Plus.
* Having fasting triglyceride level ≥400 mg/dL (≥4.52 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 calculated creatinine clearance \<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 × 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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07229118
Study Brief:
Protocol Section:
NCT07229118