A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women (NCT06720714) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
United States15 participantsStarted 2024-12-03
Plain-language 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
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
* Study participant must be minimum 18 years at the time of signing the informed consent form (ICF)
* Study participant is lactating and will be at least 6 weeks postpartum on Day 1 of the study
* Study participant has voluntarily decided, prior to having knowledge of this study, to cease breast milk feeding (by any means) in relation to her current period of lactation. Study participant agrees to cease or suspend breast milk feeding by Day 1 of the study and to not resume breast milk feeding (by any means) or donate expressed breast milk for 8 weeks following administration of rozanolixizumab. Participants may decide to resume breast milk feeding 8 weeks after administration of rozanolixizumab, with the agreement that any breast milk collected (to maintain milk supply) during that 8-week period will be discarded
* Study participant is female
A female participant is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
* A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the Sampling Period and for at least 1 week after the last dose of study treatment OR
* Not a WOCBP (ie, premenopausal female with documented hysterectomy, documented bilateral salpingectomy, or documented bilateral oophorectomy)
Exclusion criteria
* Study participant has history of breast implants, breast augmentation, or breast reduction surgery
* Study participant has received live vaccine(s) …
What they're measuring
1
Concentration of rozanolixizumab in breast milk over a 7-day Sampling Period
Timeframe: From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.