A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women

UCB

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: Rozanolixizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06720714

UP0141

Details and patient eligibility

About

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

Enrollment

15 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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) within 4 weeks prior to Screening or plans to receive such vaccines during the study
Study participant has received treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
Study participant has had exposure to more than 3 new chemical entities within 12 months prior to dosing
Study participant has had an active clinically significant infection within the last 6 weeks