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

NCT07669077 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-07-31

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

Nipocalimab

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

OTHER

Breast Milk Sampling

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-23
Primary Completion
2027-02-16
Completion
2027-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07669077 on ClinicalTrials.gov