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:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06363851
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 to 55 years old, inclusive;
* Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive;
* Protocol-defined elevated serum Lp(a) level;
* Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions;
* Willing to comply with protocol required visits and assessments, and provide written informed consent.
Exclusion Criteria:
* History or evidence of a clinically significant disorder, condition or disease;
* Received an investigational drug, vaccine or device within 3 months before dosing;
* History of evidence of malignant tumor or Gilbert syndrome;
* Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection;
* History of alcohol abuse within 12 months before dosing;
* History of drug abuse within 3 months before screening;
* History of blood donations or blood loss of 400 ml and more within 3 months before dosing;
* History of stroke or myocardial infarction within 6 months before sceening;
* Pregnant or breast-feeding women;
* Other exclusion criteria applied per protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06363851
Study Brief:
Protocol Section:
NCT06363851