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

Phase 1CompletedNCT06720714

UCB Biopharma SRL15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

RozanolixizumabDRUG

Dose formulation: Solution for injection Route of administration: Subcutaneous infusion

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

UP0141 2

San Antonio, Texas, United States

UP0141 1

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Concentration of rozanolixizumab in breast milk over a 7-day Sampling Period

The breast milk collection and sampling time points will be: within 30 minutes predose and at 0 to ≤3, ≤6, ≤9, ≤12, ≤24, ≤36, ≤48, ≤60, ≤72, ≤84, ≤96, ≤108, ≤120, ≤132 and ≤144 hours (Day 7) after the start of infusion.

Time frame: From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.

Secondary Outcomes

Estimated daily infant dosage

The estimated daily infant dosage of rozanolixizumab from breast milk will be calculated based on the concentration of rozanolixizumab in mature human breast milk for the Pharmacokinetic Set (PKS).

Time frame: From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.

Relative infant dose of rozanolixizumab from breast milk

The relative infant dose of rozanolixizumab from breast milk will be calculated as: Estimated daily infant dosage (mg/kg/day)/maternal dosage (mg/kg/day) x 100%

Time frame: From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.

Occurrence of TEAEs

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are adverse events not present prior to the pharamceutical product administration or an already present event that worsens either in intensity or frequency

Time frame: From Day 1 Visit up to the Safety Follow-Up Visit (Week 9)

Data from ClinicalTrials.gov

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