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NCT Number: NCT07669077

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

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.

Recruiting

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

ICON

Salt Lake City, Utah, 84124, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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

Treatment and study plan

Nipocalimab

Drug

Nipocalimab will be administered as an intravenous (IV) infusion.

Other names: JNJ-80202135

Breast Milk Sampling

Other

Breast milk sampling at pre-defined time points for 8 days.

Primary outcomes

  1. Concentration of Nipocalimab in Breast Milk

    Time frame: Up to Day 8

    The concentration of nipocalimab in breast milk over a 7-day sampling period (Day 1 up to Day 8) will be reported.

  2. Area Under the Curve for Breast Milk Concentration

    Time frame: Up to 168 hours postdose

    Area under the curve for breast milk concentration vs time curve from time 0 to 168 hours post-dose will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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