Healthy Participants
Conditions
Keywords
Phase 1, Healthy lactating women, zilucoplan, RA101495
Brief 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.
Interventions
DRUGZilucoplan
Dose formulation: Solution for injection. Route of administration: Subcutaneous injection.
Sponsors
UCB Biopharma SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of zilucoplan and its major metabolites (RA103488 and RA102758) in breast milk during 24 hour steady state (SS) Sampling Period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Infant Dosage of zilucoplan and its major metabolites (RA103488 and RA102758) from breast milk over a 24 hour SS Sampling Period | 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 | 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). |
| Occurrence of treatment emergent adverse events (TEAEs) | From Day 1 Visit up to the Safety Follow-Up Visit (Week 8) | 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. |
| Estimated Relative Infant Dose of ZLP and its major metabolites (RA103488 and RA102758) from breast milk over a 24 hour SS Sampling Period | 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 | 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). |
Countries
United States
Contacts
CONTACTUCB Cares
STUDY_DIRECTORUCB Cares
001 844 599 2273
Outcome results
None listed