An Open-Label, Repeated-Dose Assessment of Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
UCB Biopharma SRL
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
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 mil…
Interventions
- DrugZilucoplan
Dose formulation: Solution for injection. Route of administration: Subcutaneous injection.
Locations (2)
- UP0137 2San Antonio, Texas
- UP0137 1Salt Lake City, Utah