Clinical trial NCT06720714: A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
Official title: An Open-Label, Single-Dose Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Phase 1
Healthy lactating women
rozanolixizumab
UCB7665
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Estimated daily infant dosage
timeFrame: From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.
measure: Relative infant dose of rozanolixizumab from breast milk
timeFrame: From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.
measure: Occurrence of TEAEs
timeFrame: From Day 1 Visit up to the Safety Follow-Up Visit (Week 9)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UP0141 2
state: Texas
city: Salt Lake City
country: United States
facility: UP0141 1
state: Utah
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: