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Recruiting NCT07669077

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nipocalimab, Breast Milk Sampling.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Open-Label, Lactation Study to Assess Concentrations of Nipocalimab in Breast Milk of Healthy Lactating Women

Overview

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.

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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • ICON — Salt Lake City

Identifiers

NCT: NCT07669077 · 80202135EDI1011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗