A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women (NCT06961747) | Clinical Trial Compass
RecruitingPhase 1
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
United States15 participantsStarted 2025-07-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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 sign…
What they're measuring
1
Concentrations of zilucoplan and its major metabolites (RA103488 and RA102758) in breast milk during 24 hour steady state (SS) Sampling Period
Timeframe: 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