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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT04987320
Eligibility Criteria:
Inclusion Criteria:
Inclusion eligibility criteria will be evaluated in 2 parts during the screening period:
* Part 1: After written informed consent is obtained, subjects will provide a blood sample for a preliminary Lp(a) assessment to determine eligibility for Part 2 screening. Subjects with Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL) will be eligible to return to the CRU Part 2 screening. Subjects not eligible to return for Part 2 screening will be screen failed.
* Part 2: Eligible subjects will complete all remaining screening procedures and tests that establish eligibility within 40 days prior to the Day 1 visit.
Part 1:
* Must be a resident in mainland China, Hong Kong, or Taiwan, and of Chinese Ancestry.
* Male or female subjects, between 18 and 60 years of age (inclusive) at the time of Screening.
* Screening serum Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL).
Part 2:
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) as assessed by the Investigator (or designee).
* Body mass index between 18 and 32 kg/m\^2 (inclusive) at the time of Screening.
* Subjects who are on statin must be on a stable dose of the same statin for at least 6 weeks prior to enrollment, and plan to remain on a stable dose (i.e., no change in medication or dosage) for the duration of the study.
* Females must be of non-reproductive potential:
a. Postmenopausal defined as: i. Age of ≥ 55 years with no menses for at least 12 months; OR ii. Age of \< 55 years with no menses for at least 12 months AND with a follicle stimulating hormone (FSH) level \> 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR b. History of hysterectomy; OR c. History of bilateral oophorectomy.
Exclusion Criteria:
* History or clinical evidence of peripheral neuropathy.
* Currently receiving apheresis as lipid reducing therapy.
* History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (APTT), or platelet count outside of the laboratory's normal reference range at screening. Subjects with PT and/or APTT values that are outside of the laboratory's normal reference range at screening may still be eligible to proceed to enrollment if the results are judged by the investigator in consultation with the study medical monitor to not be clinically significant.
* History or clinical evidence of diabetes mellitus, including a fasting glucose ≥ 125 mg/dL (6.9 mmol/L) at Screening.
* Use of any herbal medicines, vitamins or dietary supplements known to affect lipid metabolism (e.g. sigh oils \> 100mg/day, red yeast extract), within 30 days prior to dosing on Day 1 and for the duration of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04987320
Study Brief:
Protocol Section:
NCT04987320