Actively Recruiting
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
Led by UCB Biopharma SRL · Updated on 2026-03-24
15
Participants Needed
2
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older at the time of signing consent
- Healthy as confirmed by medical history, physical exam, lab tests, and cardiac monitoring
- Lactating and at least 6 weeks postpartum on Day 1 of the study
- Planned to stop breastfeeding during the current lactation period before knowing about the study
- Agree to stop breastfeeding by Day 1 and not resume or donate breast milk during the study period
- Up to date with meningococcal vaccinations at least 2 weeks before first dose according to guidelines
- Able to provide signed informed consent
You will not qualify if you...
- History or presence of significant cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, or nervous system disorders affecting drug metabolism or study safety
- Any medical, obstetrical, or psychiatric condition that could affect ability to participate
- Elevated liver enzymes (ALT, AST, ALP) greater than 1.0 times the upper limit of normal, with possible retesting
- Elevated bilirubin above normal limits except isolated bilirubin under specific conditions
- History of lymphoma, leukemia, or cancer within past 5 years except certain skin cancers resected over 3 years ago
- Current or recent systemic infection within 2 weeks or infection requiring IV antibiotics within 4 weeks before first dose
- Prior history of meningococcal disease
- Positive hepatitis B surface antigen within 3 months prior to dosing
- Positive hepatitis C antibody or RNA test within 3 months prior to dosing
- Positive drug or alcohol screen before study
- Positive HIV antibody test at screening
- Positive syphilis test at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
UP0137 2
San Antonio, Texas, United States, 78209
Actively Recruiting
2
UP0137 1
Salt Lake City, Utah, United States, 84124
Actively Recruiting
Research Team
U
UCB Cares
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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