Back to search results

Nipocalimab Concentrations in Breast Milk Study

This study is looking for healthy women who are breastfeeding to understand how much of the drug nipocalimab gets into breast milk. Researchers will give participants a single dose of nipocalimab through an IV (into the vein). They will then collect breast milk samples for up to 8 days to measure the drug levels. The main goal is to see the concentration of nipocalimab in breast milk and how it changes over time. This study is for women between 5 weeks and 24 months after giving birth. The study plans to enroll 8 participants, but its current status is unclear.

Study design
This is an interventional study involving 8 healthy lactating women. It is not specified if it is randomized or blinded.
What's involved
You would receive a single intravenous (IV) infusion of nipocalimab and provide breast milk samples at specific times for up to 8 days.
Compensation
Not stated in the trial record.
Follow-up
Breast milk concentrations will be measured for up to 8 days (168 hours) after the dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07669077

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~8 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:NipocalimabBreast Milk Sampling

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concentration of Nipocalimab in Breast Milk
Measured over Up to Day 8
+1 more outcome measured

Conditions

Healthy

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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 trial measures

  • Concentration of Nipocalimab in Breast MilkUp 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.

  • Area Under the Curve for Breast Milk ConcentrationUp 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.