Healthy Participants
Conditions
Keywords
Phase 1, Healthy lactating women, rozanolixizumab, UCB7665
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
Interventions
DRUGRozanolixizumab
Dose formulation: Solution for injection Route of administration: Subcutaneous infusion
Sponsors
UCB Biopharma SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period | Predose (within 30 min) on Day 1 and at 0 to <=3, >3 to <=6, >6 to <=9, >9 to <=12, >12 to <=24, >24 to <=36, >36 to <=48, >48 to <=60, >60 to <=72, >72 to <=84, >84 to <=96, >96 to <=108, >108 to <=120, >120 to<=132, and >132 to<=144 hrs (Day 7) postdose | The concentration of Rozanolixizumab in breast milk was calculated over the 7-day sampling period. Here, '\<=' denotes 'less than or equal to'; '\>' denotes 'greater than'; 'min' indicates minutes; and 'hrs' indicates hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Daily Infant Dosage | Predose (within 30 min) on Day 1 and at 0 to <=3, >3 to <=6, >6 to <=9, >9 to <=12, >12 to <=24, >24 to <=36, >36 to <=48, >48 to <=60, >60 to <=72, >72 to <=84, >84 to <=96, >96 to <=108, >108 to <=120, >120 to<=132, and >132 to<=144 hrs (Day 7) postdose | The estimated daily infant dosage of Rozanolixizumab from breast milk was calculated based on the concentration of Rozanolixizumab in mature human breast milk. Estimated daily infant dosage (milligram per kilogram per day \[mg/kg/day\]) was equal to the milk-to-plasma ratio (M/P ratio) multiplied by the average maternal plasma concentration (Cav, plasma), and the standardized mean breastmilk intake by infant, which is 150 milliliters of breast milk per kilogram of infant body weight per day (150 mL/kg/day). |
| Relative Infant Dose of Rozanolixizumab From Breast Milk | Predose (within 30 min) on Day 1 and at 0 to <=3, >3 to <=6, >6 to <=9, >9 to <=12, >12 to <=24, >24 to <=36, >36 to <=48, >48 to <=60, >60 to <=72, >72 to <=84, >84 to <=96, >96 to <=108, >108 to <=120, >120 to<=132, and >132 to<=144 hrs (Day 7) postdose | The relative infant dose of Rozanolixizumab from breast milk was calculated by dividing the estimated daily infant dosage (mg/kg/day) by maternal dosage (mg/kg/day) and then multiplying the result by 100. |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From Day 1 Visit up to the Safety Follow-Up Visit (Day 57) | An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A Treatment-emergent adverse events (TEAEs) were defined as any adverse events with a start date/time on or after dosing of the study medication and up to 8 weeks inclusive after dosing of the study medication. The participant data was rounded to one decimal place. |
Countries
United States
Contacts
STUDY_DIRECTORUCB Cares
001 844 599 2273
Participant flow
Recruitment details
The study started to enroll participants in December 2024 and concluded in May 2025.
Pre-assignment details
The Participant Flow refers to the Safety Set (SS).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.5 years STANDARD_DEVIATION 4.6 |
| Age, Customized 18 - <65 years | 15 Participants |
| Age, Customized 65 - <85 years | 0 Participants |
| Age, Customized >= 85 years | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 12 Participants |
| Race/Ethnicity, Customized Race Black | 1 Participants |
| Race/Ethnicity, Customized Race White | 14 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 11 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
None listed