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

NCT06720714 | Completed Phase 1 FDA Drug

• 1 other identifier: UP0141
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Conditions

Healthy Participants

Keywords

Phase 1; Healthy lactating women; rozanolixizumab; UCB7665

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Estimated daily infant dosage

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

• Relative infant dose of rozanolixizumab from breast milk

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

• Occurrence of TEAEs

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

Study Arms (1)

Rozanolixizumab arm

EXPERIMENTAL

Study participants enrolled in this arm will receive a single dose of subcutaneous rozanolixizumab

Drug: Rozanolixizumab

Interventions

Rozanolixizumab DRUG

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

Also known as: UCB7665

Rozanolixizumab arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study will enroll adult (≥18 years of age) healthy lactating women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (2)

UP0141 2

San Antonio, Texas, 78209, United States

Location

UP0141 1

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

rozanolixizumab

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: December 3, 2024
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)