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:
NCT04092712
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects between the ages of 19 and 55 years, inclusive (healthy is determined by medical evaluation, including medical history, full physical examination, vital signs, electrocardiogram, and clinical laboratory tests)
* Body Mass Index of 18.0 to 32.0 kg/m2
* Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing and throughout the study
Exclusion Criteria:
* Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening
* Infection with hepatitis B or hepatitis C viruses
* History of irregular bowel movements
* History of herpes zoster
* A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
* History or presence of alcoholism or drug abuse within the past 2 years prior to dosing
* Participation in another clinical study within 30 days prior to dosing
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT04092712
Study Brief:
Protocol Section:
NCT04092712