A Study to Evaluate Zilucoplan Injected Subcutaneously Ei... | NCT06511076

NCT06511076

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Sequence AB	Experimental	Study participants randomized to this arm will receive a single subcutaneous (sc) injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) as reference and a single sc injection of zilucoplan using an autoinjector (ZLP-AI; Treatment B) as test in the treatment sequence A-B on Day 1 of each Treatment Period.	Drug: Zilucoplan
Treatment Sequence BA	Experimental	Study participants randomized to this arm will receive a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) as reference and a single sc injection of zilucoplan using an autoinjector (ZLP-AI; Treatment B) as test in the treatment sequence B-A on Day 1 of each Treatment Period.	Drug: Zilucoplan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zilucoplan	Drug	Participants will receive a single sc injection of zilucoplan in the pre-specified sequence.	Treatment Sequence AB Treatment Sequence BA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Plasma Concentration-time Curve From Time Zero (Predose [Day 1]) to Infinity (AUC) for Zilucoplan	AUC was defined as the area under the plasma concentration-time curve from time zero (predose [Day 1]) to infinity for zilucoplan.	Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose
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	AUC(0-t) was defined as the area under the plasma concentration-time curve from time 0 (predose [Day 1]) to the time of the last quantifiable concentration for zilucoplan.	Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose
Maximum Observed Plasma Concentration (Cmax) for Zilucoplan	Cmax was defined as the maximum observed plasma concentration for zilucoplan.	Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose

Secondary Outcomes

Measure	Description	Time Frame
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	An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product, whether or not considered related to the investigational medicinal product. A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first. Percentages were displayed to one decimal place and was correspond to whole participant counts due to rounding.

Eligibility Module

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.

Name	Affiliation	Role
UCB Cares	001 844 599 2273	Study Director

ID	Title	Description
FG000	Sequence: Treatment A (ZLP-PFS) - Treatment B (ZLP-AI)	Participants received a single subcutaneous (sc) injection in abdomen using zilucoplan pre-filled syringe (ZLP-PFS) (Treatment A) on Day 1 of Period 1 and a single sc injection in abdomen using zilucoplan auto-injector (ZLP-AI) (Treatment B) on Day 1 of Period 2 in the treatment sequence A-B. Each treatment period was of 35 days and was separated by 7-Days Washout period.
FG001	Sequence: Treatment B (ZLP-AI) - Treatment A (ZLP-PFS)	Participants received a single sc injection using ZLP-AI (Treatment B) on Day 1 of Period 1 and a single sc injection in abdomen using ZLP-PFS (Treatment A) on Day 1 of Period 2 in the treatment sequence B-A. Each treatment period was of 35 days and was separated by 7-Days Washout period.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Sequence: Treatment A (ZLP-PFS) - Treatment B (ZLP-AI)	Participants received a single subcutaneous (sc) injection in abdomen using zilucoplan pre-filled syringe (ZLP-PFS) (Treatment A) on Day 1 of Period 1 and a single sc injection in abdomen using zilucoplan auto-injector (ZLP-AI) (Treatment B) on Day 1 of Period 2 in the treatment sequence A-B. Each treatment period was of 35 days and was separated by 7-Days Washout period.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Plasma Concentration-time Curve From Time Zero (Predose [Day 1]) to Infinity (AUC) for Zilucoplan

AUC was defined as the area under the plasma concentration-time curve from time zero (predose [Day 1]) to infinity for zilucoplan.

The Pharmacokinetic (PK) Set consisted of all study participants who were randomized, received at least 1 dose of ZLP, and had at least 1 observable PK concentration measurement.

Posted

Geometric Mean

Geometric Coefficient of Variation

hour*nanogram per milliliters (h*ng/mL)

Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose

ID	Title	Description
OG000	ZLP-PFS	Participants received a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) on Day 1 of Treatment Period 1 and 2.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ZLP-PFS	Participants received a single sc injection of zilucoplan using pre-filled syringe (ZLP-PFS; Treatment A) on Day 1 of Treatment Period 1 and 2.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 11, 2023	Nov 14, 2025	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Nov 11, 2024	Nov 14, 2025	SAP_001.pdf