A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
Recruiting
Phase 1
Interventional Study
Healthy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 8 (estimated)
- Sponsor
- Janssen Research & Development, LLC · Industry
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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.
Trial Locations
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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 an…
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