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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
UCB Biopharma SRL
Study ID
NCT06961747
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Zilucoplan — DRUG
    Dose formulation: Solution for injection. Route of administration: Subcutaneous injection.

Study Details

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.

Key Dates

Start date
Jul 9, 2025
Status verified
Mar 2026
Primary completion
Mar 23, 2027
Completion
Mar 23, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Zilucoplan
    Study participants enrolled in this arm will receive daily ZLP injections.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UP0137 2San AntonioTexas78209-
UP0137 1Salt Lake CityUtah84124-

Find similar trials in San Antonio, TX

By research site
UP0137 2· San Antonio, TXUP0137 1· Salt Lake City, UT

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