Healthy VolunteersPhase 1NCT06511076
A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants
A Phase 1 study testing Zilucoplan in people with Healthy Volunteers, run by UCB Biopharma SRL at 1 site in Netherlands.
Trial summary
The purpose of this study is to assess the bioequivalence pharmacokinetics, safety, tolerability and device deficiencies of zilucoplan (ZLP) in healthy adult participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Zilucoplan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Aug 2024to 26 Nov 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to assess the bioequivalence pharmacokinetics, safety, tolerability and device deficiencies of zilucoplan (ZLP) in healthy adult participants
- Conditions
- Healthy Volunteers
- Being tested
- Zilucoplan
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZilucoplanDrug
Also called RA101495
Participants will receive a single sc injection of zilucoplan in the pre-specified sequence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Zilucoplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose
Secondary outcomes (4)
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.
Measured: From Day 1 to EOS visit or ET visit (up to 82 days)
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
An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- Important medical events such as (but not limited to) invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias, convulsions not resulting in hospitalization, or development of intervention dependency or intervention abuse.
Measured: From Day 1 to EOS visit or ET visit (up to 82 days)
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
An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- Important medical events such as (but not limited to) invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias, convulsions not resulting in hospitalization, or development of intervention dependency or intervention abuse.
A SADE was defined as an adverse device effect that has resulted in any of the consequences characteristic of a SAE.
Measured: From Day 1 to EOS visit or ET visit (up to 82 days)
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
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. An ADE was defined as an AE related to the use of an investigational medical device.
Measured: From Day 1 to EOS visit or ET visit (up to 82 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start5 Aug 2024
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511076
- Sponsor's protocol ID
- DV0012
- Status last verified
- Dec 2025
- First submitted
- 15 Jul 2024
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, individual patient-level data cannot be adequately anonymized as there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06511076
- Acronym / sponsor ID
- DV0012
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the bioequivalence pharmacokinetics, safety, tolerability and device deficiencies of zilucoplan (ZLP) in healthy adult participants
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: ZilucoplanStudy 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. |
| Treatment Sequence BA | Experimental | Drug: ZilucoplanStudy 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZilucoplanAlso: RA101495Participants will receive a single sc injection of zilucoplan in the pre-specified sequence. | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Area Under the Plasma Concentration-time Curve From Time Zero (Predose [Day 1]) to Infinity (AUC) for Zilucoplan
Time frame: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose
AUC was defined as the area under the plasma concentration-time curve from time zero (predose [Day 1]) to infinity for zilucoplan.
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
Time frame: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose
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.
Maximum Observed Plasma Concentration (Cmax) for Zilucoplan
Time frame: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose
Cmax was defined as the maximum observed plasma concentration for zilucoplan.
4 secondary outcomes
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
Time frame: From Day 1 to EOS visit or ET visit (up to 82 days)
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
Time frame: From Day 1 to EOS visit or ET visit (up to 82 days)
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
Time frame: From Day 1 to EOS visit or ET visit (up to 82 days)
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
Time frame: From Day 1 to EOS visit or ET visit (up to 82 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, individual patient-level data cannot be adequately anonymized as 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zilucoplan in people with Healthy Volunteers, run by UCB Biopharma SRL at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-time Curve From Time Zero (Predose [Day 1]) to Infinity (AUC) for Zilucoplan (time frame: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.