Recruiting
Phase 1

Nipocalimab

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07669077

Conditions

Healthy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Nipocalimab

Breast Milk Sampling

Study Details

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

Study ID

NCT07669077

Start date

Jun 23, 2026

Status verified date

Aug, 2026

Completion date

Feb 16, 2027

Anticipated

Primary completion date

Feb 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Nipocalimab

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

Breast Milk Sampling

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

Primary outcome measure

  • Concentration of Nipocalimab in Breast Milk [ Time Frame: Up to Day 8 ]
  • Area Under the Curve for Breast Milk Concentration [ Time Frame: Up to 168 hours postdose ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

ICON

Recruiting

Salt Lake City, Utah, United States, 84124

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.