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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT00868660
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult male and/or females, 18 to 50 years of age
* Body mass index (BMI)18-30. Chrons Inclusion
* Adult male and/or females, 18 to 60 years of age (inclusive).
* Body mass index (BMI) ≥ 18 and ≤ 30 (kg/m2).
* Crohn's Disease Activity Index (CDAI) score \< 150.
* In a stable state of Crohn's disease as per the Investigator's opinion.
* Free of steroid treatment (therapy targeted for the GI tract only) within the 3 months prior to Day 1.
Exclusion Criteria:
* History or presence of dysplasia, cancer, chronic hepatitis, HIV, tuberculosis (TB), or histoplasmosis.
* Fistula within the 3 months prior to dosing. 3. Ostomy (having ostomy now or at any time in the past). 4. Any surgery for the treatment of inflammatory bowel disease (IBD) within the 3 months prior to Day 1. 5. Short Bowel Syndrome (SBS). 6. Any other condition, chronic disease, or prior therapy, which in the opinion of the Investigator/Investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00868660
Study Brief:
Protocol Section:
NCT00868660