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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
15
Dose formulation: Solution for injection. Route of administration: Subcutaneous injection.
UP0137 2
San Antonio, Texas, United States
RECRUITINGUP0137 1
Salt Lake City, Utah, United States
RECRUITINGConcentrations of zilucoplan and its major metabolites (RA103488 and RA102758) in breast milk during 24 hour steady state (SS) Sampling Period
Maternal breast milk samples will be collected for measurement of zilucoplan and its major metabolites.
Time frame: 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
Daily Infant Dosage of zilucoplan and its major metabolites (RA103488 and RA102758) from breast milk over a 24 hour SS Sampling Period
The estimated daily infant dosage level of zilucoplan from breast milk will be calculated based on the concentration of zilucoplan in mature human breast milk for the Pharmacokinetic Set (PKS).
Time frame: 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
Occurrence of treatment emergent adverse events (TEAEs)
An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are adverse events do not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency.
Time frame: From Day 1 Visit up to the Safety Follow-Up Visit (Week 8)
Estimated Relative Infant Dose of ZLP and its major metabolites (RA103488 and RA102758) from breast milk over a 24 hour SS Sampling Period
The relative daily infant dosage level of zilucoplan from breast milk will be calculated based on the concentration of zilucoplan in mature human breast milk for the Pharmacokinetic Set (PKS).
Time frame: 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
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