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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Rozanolixizumab

• Registration Number: NCT06720714
• Lead Sponsor: UCB Biopharma SRL

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study Start: 2024-12-03
• Study First Posted: 2024-12-06
• Status Verified: 2025-05
• Primary Completion: 2025-05-12
• Study Completion: 2025-05-12
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rozanolixizumab arm	Rozanolixizumab	Study participants enrolled in this arm will receive a single dose of subcutaneous rozanolixizumab

Primary Outcome Measures

Name	Time	Method
Concentration of rozanolixizumab in breast milk over a 7-day Sampling Period	From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.	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.

Secondary Outcome Measures

Name	Time	Method
Estimated daily infant dosage	From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.	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).
Relative infant dose of rozanolixizumab from breast milk	From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.	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%
Occurrence of TEAEs	From Day 1 Visit up to the Safety Follow-Up Visit (Week 9)	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

Trial Locations

Locations (2)

UP0141 2; 🇺🇸 San Antonio, Texas, United States

UP0141 1; 🇺🇸 Salt Lake City, Utah, United States