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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02414594
Eligibility Criteria:
Inclusion Criteria:
* Must have given written informed consent and be able to comply with all study requirements
* Healthy males or females aged 18-65 inclusive and weighing ≥ 50 kg at the time of informed consent
* Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* BMI \< 35.0 kg/m2
* Subjects must have Lp(a) ≥ 75 nanomoles/liter nmol/L (30 mg/dL) at Screening
Exclusion Criteria:
* Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
* Treatment with another Study Drug, biological agent, or device within one-month of screening
* Regular use of alcohol within 6 months of Screening
* Use of concomitant drugs unless authorized by the Sponsor Medical Monitor
* Smoking \> 10 cigarettes a day
* Considered unsuitable for inclusion by the Principal Investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02414594
Study Brief:
Protocol Section:
NCT02414594