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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07471932
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent and willing and able to comply with the study protocol.
2. Healthy men or women,18 to 45 years of age (inclusive) at screening.
3. Female participants agree to use effective contraception.
4. Male volunteers agree to use barrier protection when they engage in sexual relations with women of child-bearing potential (WOCBP) or lactating women.
5. Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m\^2), inclusive, and with a minimum bodyweight of 50 kg.
6. Has the ability to communicate well with the Investigator in Dutch language and willing to comply with the study restrictions.
Exclusion Criteria:
1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the participant in the opinion of the investigator.
2. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results.
3. Use of any medications (prescription or over-the-counter \[OTC\]), within 14 days prior to IMP dosing or less than 5 half-lives (whichever is longer). An exception is made for paracetamol (up to 4 g/day).
4. If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07471932
Study Brief:
Protocol Section:
NCT07471932