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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT06867835
Eligibility Criteria:
Inclusion Criteria (Main Criteria):
* Female subjects ≥18 to 55 years of age (inclusive) and premenopausal
* Lactating, between 10 days and 6 months postpartum (inclusive).
* Exclusively breastfeeds their infant prior to participation in the study
* Is willing to pump and store breastmilk for feeding her infant for a minimum of 48 hours in advance of study initiation and discontinue breastfeeding their infant for the duration of their study participation (beginning from time of dosing with BMT) and a minimum of 24 hours following the Safety Follow-Up visit (i.e., a minimum of 48 hours following dosing with BMT).
* Ensure at the time of screening that the breastfed infant can feed from a bottle during maternal participation in the study
* The subject is not pregnant, and does not intend to become pregnant before, during, or within 1 complete menstrual cycle or 2 months after administration of study drug
* Subjects of childbearing potential who are sexually active with a nonsterilized male partner must have stable, continuous use of an acceptable method of contraception throughout the duration of the study, and for at least 60 days after the dose of study drug
Exclusion Criteria (Main Criteria):
* Breastfeeding is not well established in the mother-infant pair (e.g., poor latching of the infant or low milk supply).
* Any condition that interferes with the successful collection of milk from one or both breasts including but not limited to lactation mastitis (typically presents as a tender, hot, swollen area of the breast that may or may not involve an infection), milk blister that may present as a blocked nipple pore, breast abscess, etc.
* Has used any investigational compound and/or an experimental medical device within 28 days before Screening.
* Has taken BMT within 24 hours of participation in the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06867835
Study Brief:
Protocol Section:
NCT06867835