RecruitingPhase 1NCT06961747
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
An Open-Label, Repeated-Dose Assessment of Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
Sponsor
UCB Biopharma SRL
Enrollment
15 participants
Start Date
Jul 9, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to assess the steady state (SS) concentrations of zilucoplan (ZLP) and its major metabolites in mature breast milk of healthy study participants following injection of repeated once-daily doses of ZLP.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria7
- 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 Criteria12
- 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
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Interventions
DRUGZilucoplan
Dose formulation: Solution for injection. Route of administration: Subcutaneous injection.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06961747
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