Healthy ParticipantsPhase 1NCT06720714

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

A Phase 1 study testing Rozanolixizumab in people with Healthy Participants, run by UCB Biopharma SRL at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Rozanolixizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 2 sitesUnited States
Study dates: 3 Dec 2024to 12 May 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UP0141 1
Salt Lake City, Utah, 84124
UP0141 2
San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: An Open-Label, Single-Dose Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women

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
Being tested: Rozanolixizumab
Keywords: Phase 1, Healthy lactating women, rozanolixizumab, UCB7665

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RozanolixizumabDrug
Also called UCB7665
Dose formulation: Solution for injection Route of administration: Subcutaneous infusion

Study groups in NCT06720714
Study group	Role	What they receive
Rozanolixizumab arm	Experimental	Study participants enrolled in this arm will receive a single dose of subcutaneous rozanolixizumab Receives: Drug: Rozanolixizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period
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.
Measured: 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

Secondary outcomes (3)

Estimated Daily Infant Dosage
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).
Measured: 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
Relative Infant Dose of Rozanolixizumab From Breast Milk
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.
Measured: 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
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Measured: From Day 1 Visit up to the Safety Follow-Up Visit (Day 57)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 202412 May 2025

First posted6 Dec 2024
Study start3 Dec 2024
Primary completion12 May 2025
Study completion12 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06720714
Sponsor's protocol ID: UP0141
Status last verified: Mar 2026
First submitted: 2 Dec 2024
Last updated: 4 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Due to the small sample size in this trial, individual participant-level data cannot be adequately anonymized as there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
ClinicalTrials.gov ID: NCT06720714
Acronym / sponsor ID: UP0141
Conditions: Healthy Participants
Keywords: Phase 1, Healthy lactating women, rozanolixizumab, UCB7665
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: UCB Biopharma SRLIndustry (pharma, biotech, devices)
Study start: 3 Dec 2024 (actual)
Primary completion: 12 May 2025 (actual)
Study completion: 12 May 2025 (actual)
First posted: 6 Dec 2024 (actual)
Results: Posted 4 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rozanolixizumab arm	Experimental	Drug: RozanolixizumabStudy participants enrolled in this arm will receive a single dose of subcutaneous rozanolixizumab

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RozanolixizumabAlso: UCB7665Dose formulation: Solution for injection Route of administration: Subcutaneous infusion	Drug	Rozanolixizumab arm

Primary outcome

Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period
Time frame: 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.

3 secondary outcomes

Estimated Daily Infant Dosage
Time frame: 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
Relative Infant Dose of Rozanolixizumab From Breast Milk
Time frame: 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
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Day 1 Visit up to the Safety Follow-Up Visit (Day 57)

Results and safety

Results posted to the registry on 4 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rozanolixizumab	15	15

Primary outcome: Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms per milliter (ug/mL)

Measure	Rozanolixizumab n = 15
Predose (Day 1)	NA (NA)
0 to <=3 hours postdose (Day 1)	NA (NA)
>3 to <=6 hours postdose (Day 1)	NA (NA)
>6 to <=9 hours postdose (Day 1)	NA (NA)
>9 to <=12 hours postdose (Day 1)	NA (NA)
>12 to <=24 hours postdose (Day 1)	NA (NA)
>24 to <=36 hours postdose (Day 2)	NA (NA)
>36 to <=48 hours postdose (Day 2)	NA (NA)

Population analysed: The Pharmacokinetics-Set (PKS) included all study participants in the SS who had received a full dose of the IMP and provided at least 1 valid measurement of Rozanolixizumab concentration in plasma or breast milk. The 'overall number of participants analyzed' includes all participants evaluable for this outcome measure, while the 'number analyzed' refers to the participants evaluable for each specific category and time point.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 Visit up to the Safety Follow-Up Visit (Day 57). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rozanolixizumab	0 of 15 (0%)	11 of 15 (73.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Due to the small sample size in this trial, individual participant-level data cannot be adequately anonymized as there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Cares study director

001 844 599 2273

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rozanolixizumab in people with Healthy Participants, run by UCB Biopharma SRL at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06720714.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.