Healthy
Conditions
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.
Interventions
DRUGNipocalimab
Nipocalimab will be administered as an intravenous (IV) infusion.
OTHERBreast Milk Sampling
Breast milk sampling at pre-defined time points for 8 days.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Nipocalimab in Breast Milk | Up to Day 8 | The concentration of nipocalimab in breast milk over a 7-day sampling period (Day 1 up to Day 8) will be reported. |
| Area Under the Curve for Breast Milk Concentration | Up to 168 hours postdose | Area under the curve for breast milk concentration vs time curve from time 0 to 168 hours post-dose will be reported. |
Countries
United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed