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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT05763459
Eligibility Criteria:
Inclusion Criteria:
* Adult volunteers in general good health
* Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures
* Individuals between 18 and 65 years of age inclusive at the time of screening
* BMI is ≥ 18.0 to ≤ 32.0 kg/m2
* All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug
* All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.
Exclusion Criteria:
* Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures
* Pregnant or breastfeeding.
* Treatment with any other investigational treatment within 30 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05763459
Study Brief:
Protocol Section:
NCT05763459