Clinical trial NCT06511076: A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants
Official title: An Open-Label, Single Center, Randomized, 2-Way Crossover, Single-Dose, Bioequivalence Study of Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-Injector in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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 Screening Visit or within 3 months prior to starting IMP. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained.
* Positive hepatitis C RNA test result at the Screening Visit or within 3 months prior to first dose of IMP. NOTE: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
* Positive human immunodeficiency virus antibody test at the Screening Visit.
* Positive syphilis test at the Screening Visit.
* Positive throat swab for N. meningitidis at the Screening Visit or a prior history of meningitis.

Primary outcomes:
measure: AUC area under the plasma concentration-time curve from time 0 to infinity)
timeFrame: From Day 1 (Predose) up to Day 35 of each treatment period
measure: AUC0-t (area under the plasma concentration-time curve from time 0 to time t)
timeFrame: From Day 1 (Predose) up to Day 35 of each treatment period
measure: Cmax (maximum observed plasma concentration)
timeFrame: From Day 1 (Predose) up to Day 35 of each treatment period
Secondary outcomes:
measure: Occurrence of treatment-emergent adverse events (TEAEs) from Day 1 up to the end of study (EOS) visit or early termination (ET) visit
timeFrame: From Day 1 up to the end of study (EOS) visit or early termination (ET) visit (up to Day 77)
measure: Occurrence of serious adverse events (SAEs) from Day 1 up to the end of study (EOS) visit or early termination (ET) visit
timeFrame: From Day 1 up to the end of study (EOS) visit or early termination (ET) visit (up to Day 77)
measure: Occurrence of serious adverse device effects (SADE) from Day 1 up to the end of study (EOS) visit or early termination (ET) visit
timeFrame: From Day 1 up to the end of study (EOS) visit or early termination (ET) visit (up to Day 77)
measure: Occurrence of nonserious adverse device effects (ADE) from Day 1 up to the end of study (EOS) visit or early termination (ET) visit
timeFrame: From Day 1 up to the end of study (EOS) visit or early termination (ET) visit (up to Day 77)
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: DV0012 1
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: