A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Eli Lilly and Company
Summary
The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication. Participation in this study could last up to 94 days, including screening and follow-up period.
Eligibility
- Age range
- 0+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: Study Participants: * Mothers who are at minimum 18 years of age and their infants who are at least 36 weeks gestation age at birth and at least 3 weeks old by Study Day 0 * Multiple births may be allowed following discussion with the medical monitor. Note: in the opinion of the healthcare practitioner (HCP), there are no infant or maternal issues that would preclude the mother participant or the infant from participation * Lactation history is well established, with the mother exclusively breastfeeding her infant * Mother participant is receiving mirikizumab therapeuti…