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

ConditionHealthy

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexFemale

Age18+

SponsorJanssen Research & Development, LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Nipocalimab
Drug
Nipocalimab will be administered as an intravenous (IV) infusion.
Breast Milk Sampling
Other intervention
Breast milk sampling at pre-defined time points for 8 days.

Treatment groups

8 Participants

are divided into 1 treatment group

Group A: Healthy Lactating ParticipantsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

Up to 168 hours postdose

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov

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