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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT04535934
Eligibility Criteria:
Inclusion:
1. Ambulatory 18-40 year old adults.
2. Ability to comply with study procedures, including directly observed dosing visits and availability and use of video streaming technology.
Exclusion:
1. Inability to give informed consent
2. Pregnancy or plan to become pregnant in the next 12 months or unwillingness to use birth control
3. Current breastfeeding
4. Active psychiatric illness, social condition, or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements.
5. GFR estimate \< 60 ml/min (MDRD equation).
6. Total bilirubin and/or hepatic transaminases (ALT and AST) ≥ 2.5x upper limit of normal
7. Absolute neutrophil count ≤ 1,500/mm3, platelets count ≤ 100,000/mm3, or hemoglobin ≤ 10 g/dL.
8. Symptomatic hemoglobinopathies or active hemolysis.
9. Any laboratory value or uncontrolled medical conditions that, in the opinion of the investigators, would interfere with the study conditions such as, heart disease and/or cancer.
10. Any investigational agents within 30 days of enrollment.
11. Plan to donate blood or plasma during study enrollment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04535934
Study Brief:
Protocol Section:
NCT04535934