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NCT07669077From ClinicalTrials.govRecruiting

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

  • Healthy

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
8
Started
23 June 2026
Main results due
16 February 2027
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Women only.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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 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

What this study is about

In the sponsor’s own words, from the registry.

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 sites(1)

  • ICON

    Salt Lake City, Utah, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07669077. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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