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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT06645704
Eligibility Criteria:
Inclusion Criteria:
* Males aged 18 to 55 years
* Body mass index of 18 to 32 kg/m2 and body weight of 55 to 100 kg
* Negative result for HIV, HBV, and HCV at Screening
* Male subjects with female partners of reproductive potential must be surgically sterile or use adequate birth control
* No use of tobacco or nicotine containing products within the past 6 months
Exclusion Criteria:
* History or presence of any condition or prior surgery that could pose a significant risk in the opinion of the investigator
* History of malignancy within the past 5 years
* History of any serious allergic reactions or hypersensitivity
* Recent history of incomplete bladder emptying with voiding or awakening more than once at a night to void
* Usual habit of bowel movements of less than 1 or more than 3 bowel movements per day
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06645704
Study Brief:
Protocol Section:
NCT06645704