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NCT07669077 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
A Phase 1 study, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT07669077: Recruiting Phase 1 study, sponsored by Janssen Research & Development.
NCT07669077 is a Phase 1 study that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07669077, a Phase 1 study, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
The concentration of nipocalimab in breast milk over a 7-day sampling period (Day 1 up to Day 8) will be reported.
Interventions
- DRUG Nipocalimab
- OTHER Breast Milk Sampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2026-06-26 |
| Est. Completion | 2027-02-16 |
| Phase | Phase 1 |
What NCT07669077 shows while recruiting
NCT07669077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Nipocalimab is the first listed.
NCT07669077 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07669077 about?
NCT07669077 is a clinical study titled "A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women". 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.
What is the current status of trial NCT07669077?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2026-06-26. Estimated completion is 2027-02-16.
What interventions are being tested in trial NCT07669077?
The interventions under investigation include: Nipocalimab (DRUG), Breast Milk Sampling (OTHER).
Who is sponsoring clinical trial NCT07669077?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07669077's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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