The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics \[PK\]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Nipocalimab will be administered as an intravenous (IV) infusion.
Breast milk sampling at pre-defined time points for 8 days.
ICON
Salt Lake City, Utah, United States
RECRUITINGConcentration of Nipocalimab in Breast Milk
The concentration of nipocalimab in breast milk over a 7-day sampling period (Day 1 up to Day 8) will be reported.
Time frame: Up to Day 8
Area Under the Curve for Breast Milk Concentration
Area under the curve for breast milk concentration vs time curve from time 0 to 168 hours post-dose will be reported.
Time frame: Up to 168 hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.