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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT03103412
Eligibility Criteria:
Inclusion Criteria:
* Male or female between 18 to 55 years old
* Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
* Body Mass Index (BMI) 18 to 32 kg/m2
* Willing and able to give informed consent
* Additional inclusion criteria apply
Inclusion Criteria for Ulcerative Colitis (UC) subjects:
* Subject has a history of UC
* Subject is either not taking any medication for UC or has been taking a stable dose of ulcerative colitis medications for ≥ 14 days
* Additional inclusion criteria apply
Exclusion Criteria:
* Is positive for hepatitis A, B or C, HIV or tuberculosis
* Has clinically significant abnormalities in baseline laboratory evaluations
* Subject has a clinically significant abnormal electrocardiogram (ECG)
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening (or within 60 days prior to screening if investigational drug was a biologic, or is currently participating in another trial of an investigational drug (or medical device)
* Additional exclusion criteria apply
Exclusion Criteria for Healthy Subjects:
* Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy or standard daily multivitamin.
* Additional exclusion criteria apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03103412
Study Brief:
Protocol Section:
NCT03103412