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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT06821750
Eligibility Criteria:
Key Inclusion Criteria:
* Healthy males aged 18 to 45 years and healthy females aged 18 to 55 years
* Body Mass Index (BMI) of 16-32 kg/m2, and a total body weight greater than 50 kg (110 lb); for Japanese participants only, a total body weight greater than 45 kg
* for Japanese participants only, enrolling as Japanese must have 4 biological grandparents who were born in Japan.
Key Exclusion Criteria:
* Evidence or history of clinically significant medical or psychiatric conditions
* Prior or current use of any prohibited medications
* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
* Pregnant or breastfeeding females, males with partners currently pregnant, or males or females pursuing artificial reproductive technologies
* Use of tobacco/nicotine containing products
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06821750
Study Brief:
Protocol Section:
NCT06821750