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Phase 1 N=14 Randomized Basic Science

A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants

Healthy Volunteers

Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Area Under the Plasma Concentration-time Curve From Time Zero (Predose [Day 1]) to Infinity (AUC) for Zilucoplan — 950930; 932740 hour*nanogram per milliliters (h*ng/mL)

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Zilucoplan (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
UCB Biopharma SRL
Primary completion
Nov 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Plasma Concentration-time Curve From Time Zero (Predose [Day 1]) to Infinity (AUC) for Zilucoplan
950930; 932740
PRIMARY
Area Under the Plasma Concentration-time Curve From Time 0 (Predose [Day 1]) to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Zilucoplan
921190; 904500
PRIMARY
Maximum Observed Plasma Concentration (Cmax) for Zilucoplan
5599.8; 5597.6
SECONDARY
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) From Day 1 up to the End of Study (EOS) Visit or Early Termination (ET) Visit
57.1; 57.1
SECONDARY
Percentage of Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) From Day 1 up to the End of Study (EOS) Visit or Early Termination (ET) Visit
0; 0
SECONDARY
Percentage of Participants With Serious Adverse Device Effects (SADE) From Day 1 up to the End of Study (EOS) Visit or Early Termination (ET) Visit
0; 0
SECONDARY
Percentage of Participants With Non-serious Adverse Device Effects (ADE) From Day 1 up to the End of Study (EOS) Visit or Early Termination (ET) Visit
0; 0

Summary

The purpose of this study is to assess the bioequivalence pharmacokinetics, safety, tolerability and device deficiencies of zilucoplan (ZLP) in healthy adult participants

Eligibility Criteria

Inclusion Criteria

  • Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • Participants must be vaccinated with a quadrivalent vaccine and serogroup B vaccine against meningococcal infections (N. meningitidis) at least 2 weeks before the first administration of IMP if not previously vaccinated within 3 years prior to the start of IMP administration. Study participants who are not previously vaccinated may receive Menactra® (quadrivalent vaccine) and Bexsero® (serogroup B vaccine) during the Screening Period, 2 weeks prior to initiating IMP.
  • Body mass index (BMI) ≥18.5 to ≤30.0kg/m2 at the Screening Visit.
  • Male and/or female:
  • A male participant must agree to use contraception during the Treatment Period as detailed in Appendix 4 of the protocol and for at least 40 days (approximately 5 half lives) after the last dose of IMP and refrain from donating sperm during this period.
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a female/woman of childbearing potential (WOCBP) OR
  • A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 40 days (approximately 5 half lives), corresponding to time needed to eliminate IMP after the last dose of IMP.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.

Exclusion Criteria

  • Participant has a history of or current significant medical disorder, psychiatric disorder, or laboratory abnormality that in the opinion of the Investigator makes the study participant unsuitable for participation in the study, including any previous 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 IMP; or interfering with the interpretation of data.
  • Current or recent systemic infection within 2 weeks before the first administration of IMP or infection requiring intravenous antibiotics within 4 weeks before the first administration of IMP.
  • Current history of alcohol or drug use disorder, as defined in Diagnostic and Statistical Manual of Mental Disorders V, within the previous 6 months.
  • Participant has a known hypersensitivity to any components of the IMP or comparative drugs (and/or an investigational device) as stated in the protocol.
  • Intended use of over-the-counter or prescription medication, vitamins, herbal/traditional medicines (including St John's Wort) or dietary supplements (excluding medicines for external use), with the exception of those specified in the Protocol, within 2 weeks before the first administration of IMP.
  • Participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids, phenobarbital, isoniazid, phenytoin, rifampicin) within 2 months before the first administration of IMP.
  • Participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study.
  • Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days or 5 half-lives (whichever is longer), or is currently participating in another study of an IMP (and/or an investigational device).
  • Participants with clinically relevant abnormalities in a standard 12-lead electrocardiogram (ECG) at the Screening Visit as judged by the Investigator.
  • Presence of hepatitis B surface antigen at the Screening Visit or within 3 months prior to dosing.
  • Positive hepatitis C antibody test result at the Scree
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06511076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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