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RecruitingNCT07669077Updated Sep 29, 2026

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

A Phase 1 interventional study of Nipocalimab and Breast Milk Sampling in Healthy, sponsored by Janssen Research & Development, LLC. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Healthy Lactating Participants

    A single dose of nipocalimab will be administered to healthy lactating participants on Day 1. Breast milk samples will be collected and pharmacokinetic (PK) assessments will be done for the analysis of nipocalimab concentrations for up to Day 8.

    Drug: Nipocalimab · Other: Breast Milk Sampling

Interventions

  • DrugNipocalimab

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

    Also known as: JNJ-80202135

  • OtherBreast Milk Sampling

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

05

What researchers measure

Primary outcomes

  1. Concentration of Nipocalimab in Breast Milk

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

    Time frame: Up to Day 8

  2. Area Under the Curve for Breast Milk Concentration

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

    Time frame: Up to 168 hours postdose

06

Study locations

1 of 1 sites recruiting
  • ICON
    Salt Lake City, Utah 84124, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07669077
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Jun 25, 2026
Start date
Jun 23, 2026
Primary completion
Feb 16, 2027 (estimated)
Completion
Feb 16, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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