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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT04224857
Eligibility Criteria:
Inclusion Criteria:
PART A (Healthy Volunteers)
* Male subject in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening
* Between 18 and 45 years of age, inclusive.
* Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive).
PART B (Adult Ulcerative Colitis)
* Male and Female patients 18 years and older
* Documented diagnosis of UC for at least 3 months duration
* Stable mild to moderate UC, as defined by the following criteria: Total Mayo score (excluding PGA) at least 3 but not greater than 7:
* Patients must have failed or demonstrated intolerance to aminosalicylates (e.g., 5-aminosalicylic acid, mesalamine)
Exclusion Criteria:
PART A and PART B
* Known hypersensitivity or allergy to AMT-101 or excipient contained in the drug formulation.
* Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
PART B
* Clinical findings of Crohn's disease
* A prior history of surgery for UC
* Prior use of integrin antagonists (vedolizumab, natalizumab), JAK kinase inhibitors (tofacitinib), cyclosporin or tacrolimus
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04224857
Study Brief:
Protocol Section:
NCT04224857