At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled / 15 target
Drug / intervention
Rozanolixizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Dose Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
In Brief
A Phase 1 clinical trial evaluating Rozanolixizumab for Healthy Participants. Completed, enrolled 15 participants across 2 sites.
Detailed Summary
The purpose of the study is to assess the concentration of rozanolixizumab in mature breast milk of healthy study participants following administration of a single dose of rozanolixizumab
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Participants
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
Enrollment StartDec 2024
First PostedDec 2024
Primary CompletionMay 2025
TodayJul 2026
First PostedDec 6, 2024
Enrollment StartDec 3, 2024
Primary CompletionMay 12, 2025
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 1.6 years ago
Arms & Interventions
Rozanolixizumab armexperimental
Study participants enrolled in this arm will receive a single dose of subcutaneous rozanolixizumab
Drug: Rozanolixizumab
Interventions
Rozanolixizumabdrug
Dose formulation: Solution for injection Route of administration: Subcutaneous infusion