A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
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.
| Condition(s) | Healthy Participants |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 | 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 * S |
| Ages | 18 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | UCB Biopharma SRL |
| Locations | San Antonio, Texas, United States; Salt Lake City, Utah, United States |
| Start date | 2025-07-09 |
| NCT ID | NCT06961747 |
| Official listing | https://clinicaltrials.gov/study/NCT06961747 |