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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT03995550
Eligibility Criteria:
Key inclusion Criteria:
* Body mass index of 18.0-32.0 kg/m2, inclusive.
* In good health at screening and check-in as judged by the investigator based on medical history, physical examination, vital signs assessment, 12-lead electrocardiogram, and clinical laboratory evaluations:
* Aspartate aminotransferase and alanine aminotransferase values ≤1.5 times the upper limit of normal.
* Congenital nonhaemolytic hyperbilirubinaemia (including suspicion of Gilbert's syndrome) is not acceptable.
* Haemoglobin value, neutrophil count, and lymphocyte count ≥ the lower limit of normal.
* Female subjects of childbearing potential must use a highly effective form of birth control, in conjunction with adequate barrier contraception, from randomisation until 90 days after the follow-up visit.
* Male subjects with female partner of childbearing potential must use adequate male barrier contraception, in conjunction with a highly effective form of female contraception for the partner, from randomisation until 90 days after the follow-up visit.
Key exclusion criteria:
* Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
* Any medication, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to the first dose.
* History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose.
* Current active tuberculosis based on QuantiFERON-TB Gold test.
* Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibodies at screening.
* Electrocardiogram abnormalities at screening or check-in.
* Smoking of \>10 cigarettes per day, on average, within the last 3 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03995550
Study Brief:
Protocol Section:
NCT03995550