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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zilucoplan | Experimental | Study participants enrolled in this arm will receive daily ZLP injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zilucoplan | Drug | Dose formulation: Solution for injection. Route of administration: Subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCB Cares | Contact | +18445992273 | ucbcares@ucb.com |
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UP0137 2 | Recruiting | San Antonio | Texas | 78209 | United States | |
| UP0137 1 |
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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| ID | Term |
|---|---|
| C000719268 | zilucoplan |
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| 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. | 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). | 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 |
| Recruiting |
| Salt Lake City |
| Utah |
| 84124 |
| United States |