Study of Zilucoplan in Breast Milk of Healthy Lactating Women
This study is looking at how much zilucoplan, a medication given by injection under the skin, and its main breakdown products (metabolites) get into breast milk. Researchers want to understand the levels of zilucoplan in breast milk after healthy lactating women receive daily doses. You can join if you are a healthy woman, at least 18 years old, and at least 6 weeks postpartum (after giving birth). The study aims to measure these levels over a 24-hour period after a dose. Fifteen women are planned to participate, but the current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 15 healthy lactating women. It is not specified if it is randomized, blinded, or what phase it is.
- What's involved
- You would receive repeated once-daily injections of zilucoplan. Breast milk samples would be collected at specific times on Day 10, both before and at various intervals after your dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Breast milk concentrations are measured over a 24-hour period on Day 10.
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NCT06961747
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
Recruiting
PHASE1Ages 18+InterventionalBasic scienceUCB Biopharma SRL
~15 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Zilucoplan
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concentrations of zilucoplan and its major metabolites (RA103488 and RA102758) in breast milk during 24 hour steady state (SS) Sampling Period
Measured over 30 minutes predose on Day 10 and at prespecified intervals (0 to ≤3, >3 to ≤6, >6 to ≤9, >9 to ≤12, and >12 to ≤24 hours) postdose on Day 10
Conditions
Where it's being run
2 sites across 2 statesTexas1
Utah1
Study leadership
- UCB Cares · STUDY_DIRECTOR · 001 844 599 2273
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Study participant must be minimum 18 years at the time of signing the Informed consent form (ICF)
Study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Study participant is lactating and will be at least 6 weeks postpartum on Day 1 of the study
Study participant has already planned, prior to having knowledge of this study, to cease breast milk feeding (by any means) in relation to her current period of lactation
Study participant agrees to cease breast milk feeding by Day 1 of the study and to not resume breast milk feeding (by any means and of any infant) or donate breast milk following study end for the remainder of her current period of lactation
Study participant is up to date with vaccinations against meningococcal bacteria (serogroups A, C, W, Y, and B) at least 2 weeks before the first administration of study medication according to the current (at the time of study participant consent) Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor
Study participant is capable of giving signed informed consent
Exclusion
Study participant has a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study medication; or interfering with the interpretation of data
Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
Study participant has bilirubin \>1.0xULN (isolated bilirubin \<1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). For participants with a Baseline result \>ULN for total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the eCRF
Study participant has a history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Study participant has current or recent systemic infection within 2 weeks before the first administration of study medication or infection requiring intravenous antibiotics within 4 weeks before the first administration of study medication. Note: Study participants with mastitis at Screening that does not meet the criteria for clinically significant infection may be rescreened after the infection is completely resolved
Study participant has a prior history of meningococcal disease
Study participant has presence of hepatitis B surface antigen at Screening or within 3 months prior to dosing
Study participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to starting study medication
Study participant has a positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study medication
Study participant has a positive prestudy drug and/or alcohol screen
Study participant has a positive human immunodeficiency virus antibody test at the Screening Visit
Study participant has a positive syphilis test at the Screening Visit
What this trial measures
- Concentrations of zilucoplan and its major metabolites (RA103488 and RA102758) in breast milk during 24 hour steady state (SS) Sampling Period30 minutes predose on Day 10 and at prespecified intervals (0 to ≤3, >3 to ≤6, >6 to ≤9, >9 to ≤12, and >12 to ≤24 hours) postdose on Day 10
Maternal breast milk samples will be collected for measurement of zilucoplan and its major metabolites.