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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT05362695
Eligibility Criteria:
Inclusion Criteria:
* Males and female subjects of non-childbearing potential
* Ages 18 to 60 years
* Medically healthy with no clinically significant findings during medical evaluation including physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
* Body mass index (BMI) within the range 18.5 to 35.0 kg/m\^2 (inclusive) at the Screening Visit.
* Male subjects and female partners are willing to use double-barrier method of contraception during the study.
Exclusion Criteria:
* Evidence or history of clinically significant acute or chronic disease, or clinically significant illness within 30 days of the Screening Visit.
* History of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products.
* History of any condition that would interfere with their ability to receive an enema, or has had difficulty receiving an enema in the past.
* Recent history of anal fissure, anal abscess, complicated hemorrhoids, or presence or history of inflammatory bowel disease.
* Abnormal laboratory tests or clinically significant findings on safety tests conducted at the Screening Visit or at Check-in.
* Positive serology for human immunodeficiency virus (HIV) 1, HIV 2, or hepatitis B surface antigen (HBsAg), or positive for anti-HIV 1, anti-HIV 2, or anti hepatitis C virus (HCV) antibodies at the Screening Visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05362695
Study Brief:
Protocol Section:
NCT05362695