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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07669077
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nipocalimab — DRUG
    Nipocalimab will be administered as an intravenous (IV) infusion.
  • Breast Milk Sampling — OTHER
    Breast milk sampling at pre-defined time points for 8 days.

Study Details

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.

Key Dates

Start date
Jun 26, 2026
Status verified
Jul 2026
Primary completion
Feb 16, 2027
Completion
Feb 16, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Healthy Lactating Participants
    A single dose of nipocalimab will be administered to healthy lactating participants on Day 1. Breast milk samples will be collected and pharmacokinetic (PK) assessments will be done for the analysis of nipocalimab concentrations for up to Day 8.

Primary Outcome Measure

Concentration of Nipocalimab in Breast Milk [ Time Frame: Up to Day 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ICONSalt Lake CityUtah84124-

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ICON· Salt Lake City, UT

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