A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
ConditionHealthy
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- Nipocalimab
- Breast Milk Sampling
Treatment groups
8 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov