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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
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.
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
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.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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?
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.