Clinical Trial

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

Name: A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women — clinical trial record (NCT07669077)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Recruiting Phase 1

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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.

Protocol Amendment History 1 change

critical Recruitment opened 2026-07-07

Trial Details

NCT Number	NCT07669077
Lead Sponsor	Janssen Research & Development, LLC
Conditions	Healthy
Enrollment	8 participants
Start Date	2026-06-26
Primary Completion	2027-02-16 (estimated)
Study Completion	2027-02-16 (estimated)
Updated on ClinicalTrials.gov	2026-07-06