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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT06345794
Eligibility Criteria:
Inclusion Criteria:
* Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²)
* Males who agree to follow contraceptive requirements and women of not childbearing potential
* Have body weight greater than or equal to (\>=) 50 Kilograms at screening.
* Must have a negative Interferon-Gamma Release Assays (IGRA) testing at screening
* Must have been stopped all the prescribed medication at least 14 days prior to admission to the clinical site
* Ability and willingness to abstain from alcohol, caffeine, and methylxanthine-containing beverages or food 2 days prior to admission to the clinical site
* Abstain from any strenuous physical exercise from 4 days prior to admission and during confinement at the clinical site
Exclusion Criteria:
* Have a history of relevant drug and/or food allergies, or sensitivity to medications used in the current study
* Females participants who are currently breastfeeding
* Have History of alcohol abuse or drug addiction
* Unable to abstain from tobacco products within the 2 days prior to admission and during confinement at the clinical site
* Have Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies
* Consumption of any nutrients known to modulate CYP450 enzymes activity
* Are immunocompromised
* Have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette-Guérin within 28 days of screening or intend to receive them during the study
* Have had any malignancy within the past 5 years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06345794
Study Brief:
Protocol Section:
NCT06345794