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

NCT07669077 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 80202135EDI1011
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to Day 8

• 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.

  Up to 168 hours postdose

Study Arms (1)

Healthy Lactating Participants

EXPERIMENTAL

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

Nipocalimab DRUG

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

Also known as: JNJ-80202135

Healthy Lactating Participants

Breast Milk Sampling OTHER

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

Healthy Lactating Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

ICON

Salt Lake City, Utah, 84124, United States

RECRUITING

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 25, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): February 16, 2027
• Study Completion (Estimated): February 16, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)