Healthy ParticipantsPhase 1NCT06961747
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
A Phase 1 study testing Zilucoplan in people with Healthy Participants, run by UCB Biopharma SRL at 2 sites in United States.
Trial summary
The purpose of this study is to assess the steady state (SS) concentrations of zilucoplan (ZLP) and its major metabolites in mature breast milk of healthy study participants following injection of repeated once-daily doses of ZLP. 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?
- Zilucoplan
- 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
- 9 Jul 2025to 23 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Study participant is lactating and will be at least 6 weeks postpartum on Day 1 of the study
- Study participant has already planned, 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 breast milk feeding by Day 1 of the study and to not resume breast milk feeding (by any means and of any infant) or donate breast milk following study end for the remainder of her current period of lactation
- Study participant is up to date with vaccinations against meningococcal bacteria (serogroups A, C, W, Y, and B) at least 2 weeks before the first administration of study medication according to the current (at the time of study participant consent) Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor
- Study participant is capable of giving signed informed consent
Who cannot join
- Study participant has a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study medication; or interfering with the interpretation of data
- Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- Study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN). Tests that result in ALT, AST, or ALP up to 25 percentage (%) above the exclusion limit may be repeated once for confirmation. This includes rescreening. If the repeat values are below the ULN, the study participant will be considered to not meet the exclusion criteria
- Study participant has bilirubin >1.0xULN (isolated bilirubin <1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). For participants with a Baseline result >ULN for total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the eCRF
- Study participant has a history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Study participant has current or recent systemic infection within 2 weeks before the first administration of study medication or infection requiring intravenous antibiotics within 4 weeks before the first administration of study medication. Note: Study participants with mastitis at Screening that does not meet the criteria for clinically significant infection may be rescreened after the infection is completely resolved
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- Study participant has a prior history of meningococcal disease
- Study participant has presence of hepatitis B surface antigen at Screening or within 3 months prior to dosing
- Study participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to starting study medication
- Study participant has a positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study medication
- Study participant has a positive prestudy drug and/or alcohol screen
- Study participant has a positive human immunodeficiency virus antibody test at the Screening Visit
- Study participant has a positive syphilis test at the Screening Visit
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UP0137 1
Salt Lake City, Utah, 84124
- Recruiting
UP0137 2
San Antonio, Texas, 78232
About this study
Official title: An Open-Label, Repeated-Dose Assessment of Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
The purpose of this study is to assess the steady state (SS) concentrations of zilucoplan (ZLP) and its major metabolites in mature breast milk of healthy study participants following injection of repeated once-daily doses of ZLP.
- Conditions
- Healthy Participants
- Being tested
- Zilucoplan
- Keywords
- Phase 1, Healthy lactating women, zilucoplan, RA101495
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZilucoplanDrug
Also called RA101495
Dose formulation: Solution for injection. Route of administration: Subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Zilucoplan | Experimental | Study participants enrolled in this arm will receive daily ZLP injections. Receives: Drug: Zilucoplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of zilucoplan and its major metabolites (RA103488 and RA102758) in breast milk during 24 hour steady state (SS) Sampling Period
Maternal breast milk samples will be collected for measurement of zilucoplan and its major metabolites.
Measured: 30 minutes predose on Day 10 and at prespecified intervals (0 to ≤3, >3 to ≤6, >6 to ≤9, >9 to ≤12, and >12 to ≤24 hours) postdose on Day 10
Secondary outcomes (3)
Daily Infant Dosage of zilucoplan and its major metabolites (RA103488 and RA102758) from breast milk over a 24 hour SS Sampling Period
The estimated daily infant dosage level of zilucoplan from breast milk will be calculated based on the concentration of zilucoplan in mature human breast milk for the Pharmacokinetic Set (PKS).
Measured: 30 minutes predose on Day 10 and at prespecified intervals (0 to ≤3, >3 to ≤6, >6 to ≤9, >9 to ≤12, and >12 to ≤24 hours) postdose on Day 10
Occurrence of treatment emergent adverse events (TEAEs)
An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are adverse events do not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency.
Measured: From Day 1 Visit up to the Safety Follow-Up Visit (Week 8)
Estimated Relative Infant Dose of ZLP and its major metabolites (RA103488 and RA102758) from breast milk over a 24 hour SS Sampling Period
The relative daily infant dosage level of zilucoplan from breast milk will be calculated based on the concentration of zilucoplan in mature human breast milk for the Pharmacokinetic Set (PKS).
Measured: 30 minutes predose on Day 10 and at prespecified intervals (0 to ≤3, >3 to ≤6, >6 to ≤9, >9 to ≤12, and >12 to ≤24 hours) postdose on Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start9 Jul 2025
- Primary completion23 Mar 2027 (estimated)
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
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
- NCT06961747
- Sponsor's protocol ID
- UP0137
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- 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, IPD cannot be adequately anonymized i.e., 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Repeated-Dose Assessment of Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
- ClinicalTrials.gov ID
- NCT06961747
- Acronym / sponsor ID
- UP0137
- Conditions
- Healthy Participants
- Keywords
- Phase 1, Healthy lactating women, zilucoplan, RA101495
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
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 this study is to assess the steady state (SS) concentrations of zilucoplan (ZLP) and its major metabolites in mature breast milk of healthy study participants following injection of repeated once-daily doses of ZLP.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zilucoplan | Experimental | Drug: ZilucoplanStudy participants enrolled in this arm will receive daily ZLP injections. |
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 overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Study participant is lactating and will be at least 6 weeks postpartum on Day 1 of the study
- Study participant has already planned, 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 breast milk feeding by Day 1 of the study and to not resume breast milk feeding (by any means and of any infant) or donate breast milk following study end for the remainder of her current period of lactation
Key exclusion criteria (13 listed)
- Study participant has a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study medication; or interfering with the interpretation of data
- Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- Study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN). Tests that result in ALT, AST, or ALP up to 25 percentage (%) above the exclusion limit may be repeated once for confirmation. This includes rescreening. If the repeat values are below the ULN, the study participant will be considered to not meet the exclusion criteria
- Study participant has bilirubin >1.0xULN (isolated bilirubin <1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). For participants with a Baseline result >ULN for total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the eCRF
- Study participant has a history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
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 |
|---|---|---|
| ZilucoplanAlso: RA101495Dose formulation: Solution for injection. Route of administration: Subcutaneous injection. | Drug | Zilucoplan |
Primary outcome
Concentrations of zilucoplan and its major metabolites (RA103488 and RA102758) in breast milk during 24 hour steady state (SS) Sampling Period
Time frame: 30 minutes predose on Day 10 and at prespecified intervals (0 to ≤3, >3 to ≤6, >6 to ≤9, >9 to ≤12, and >12 to ≤24 hours) postdose on Day 10
Maternal breast milk samples will be collected for measurement of zilucoplan and its major metabolites.
3 secondary outcomes
Daily Infant Dosage of zilucoplan and its major metabolites (RA103488 and RA102758) from breast milk over a 24 hour SS Sampling Period
Time frame: 30 minutes predose on Day 10 and at prespecified intervals (0 to ≤3, >3 to ≤6, >6 to ≤9, >9 to ≤12, and >12 to ≤24 hours) postdose on Day 10
Occurrence of treatment emergent adverse events (TEAEs)
Time frame: From Day 1 Visit up to the Safety Follow-Up Visit (Week 8)
Estimated Relative Infant Dose of ZLP and its major metabolites (RA103488 and RA102758) from breast milk over a 24 hour SS Sampling Period
Time frame: 30 minutes predose on Day 10 and at prespecified intervals (0 to ≤3, >3 to ≤6, >6 to ≤9, >9 to ≤12, and >12 to ≤24 hours) postdose on Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., 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.
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 Zilucoplan 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 13 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: looking for participants now, as of the sponsor's last update on 27 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCB Cares (+18445992273, ucbcares@ucb.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of zilucoplan and its major metabolites (RA103488 and RA102758) in breast milk during 24 hour steady state (SS) Sampling Period (time frame: 30 minutes predose on Day 10 and at prespecified intervals (0 to ≤3, >3 to ≤6, >6 to ≤9, >9 to ≤12, and >12 to ≤24 hours) postdose on Day 10). 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 27 Aug 2026.