A Phase 1, Open-Label, Lactation Study to Assess Concentrations of Nipocalimab in Breast Milk of Healthy Lactating Women

Janssen Research & Development, LLC

Summary

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.

Eligibility

Age range: 18+ years
Sex: Female
Healthy volunteers: Yes

Detailed criteria

Inclusion criteria: * Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening * Study participant must have good venous accessibility in both arms * Study participant must be between 5 weeks and 24 months post-partum, inclusive, on Day -1 * Study participant must agree, when nipple cream is needed during the assessment phase, to use only lanolin nipple cream * Study participant must have well established lactation and must be exclusively breast-feeding her infant (or not providing more th…

Interventions

Drug
Nipocalimab
Nipocalimab will be administered as an intravenous (IV) infusion.
Other
Breast Milk Sampling
Breast milk sampling at pre-defined time points for 8 days.

Location

ICON
Salt Lake City, Utah

A Phase 1, Open-Label, Lactation Study to Assess Concentrations of Nipocalimab in Breast Milk of Healthy Lactating Women

Summary

Eligibility

Interventions

Location

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Details

Conditions