RecruitingPhase 1NCT07669077

A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women

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

Sponsor

Janssen Research & Development, LLC

Enrollment

8 participants

Start Date

Jun 23, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 than 1 supplemental bottle of formula/day) when enrolled in the study

Exclusion Criteria5

Study participant has history of breast implants, breast augmentation, or breast reduction surgery
Study participant currently has active or unresolved mastitis at screening or Day -1
Study participant currently has or had an active clinically significant infection within the last 6 weeks
Study participant has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol-specified assessments
Study participant has suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients

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