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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT06911567
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 18.5 kg/m2 to 32.0 kg/m2 (inclusive)
* Females of childbearing potential agree to take appropriate measures to prevent pregnancy during the study
* Males who do not have a documented vasectomy or are not congenitally sterile must agree to abstinence or use of barrier method with spermicide with female partner. Male participant who is having sexual intercourse with a woman of childbearing potential who is not currently pregnant will be advised of her requirement to use an additional highly effective contraceptive method
* NOTE - Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
* Participation in another clinical trial simultaneously
* Females who are lactating, breastfeeding, or intends to become pregnant over the course of the study
* History of alcohol, drug or any other substance, abuse, addiction or dependence in the last 12 months (except for caffeine)
* Major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of IMP, or surgery scheduled during the study or follow-up period
* Donated blood or blood products (eg, white blood cells \[WBCs\], platelets, etc.) within the 60 days before screening, or has donated blood or blood products at least twice within the 6 months before screening, or has donated plasma within 7 days of the screening visit or has received blood or blood products in the 6 weeks before screening
* Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope, or previous personal treatment for high blood pressure
* NOTE - Additional criteria apply, please contact the investigator for more information
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06911567
Study Brief:
Protocol Section:
NCT06911567