Nipocalimab in breast milk after a single IV dose in healthy lactating women
Official title: A Phase 1, Open-Label, Lactation Study to Assess Concentrations of Nipocalimab in Breast Milk of Healthy Lactating Women
Run by Janssen Research & Development, LLC · NCT07669077 · Data updated 2026-11-12
This study tests how much nipocalimab shows up in breast milk after a single IV dose in healthy breastfeeding women.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 8 (estimated) |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | nipocalimab |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | June 23, 2026 |
| Main results expected | February 16, 2027 |
| Study ends | February 16, 2027 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07669077 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy lactating women between 5 weeks and 24 months postpartum who are exclusively breastfeeding and have good venous access.
✕Probably not a fit
Participants who are not exclusively breastfeeding, or those with recent infection, breast surgery, or active mastitis, may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional study evaluating the pharmacokinetics of nipocalimab in breast milk following a single intravenous administration. Healthy lactating participants will be monitored to measure drug concentrations in milk over time. Primary goals are to characterize exposure in milk and assess any safety signals during the early post-dose period. Participants must be exclusively breastfeeding and meet specific venous access and health criteria, with exclusions for recent infections or breast surgery. The study is led by Janssen Research & Development with ICON as the site partner in Salt Lake City, Utah.
Why it matters
Potential benefit: If successful, the study could inform safety considerations for Nipocalimab exposure in breast milk.
How similar studies have gone: Prior pharmacokinetic studies have established methods to measure drugs in breast milk; this study applies established PK approaches to Nipocalimab in a specific population.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.