Healthy Study ParticipantsPhase 1NCT05292131

A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants

A Phase 1 study testing bimekizumab in people with Healthy Study Participants, run by UCB Biopharma SRL at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to compare the pharmacokinetics (PK), safety and tolerability of a single subcutaneous (sc) dose of bimekizumab (BKZ) when administered using bimekizumab-autoinjector (AI)-2mL presentation versus bimekizumab-AI-2x1mL presentation in healthy study participants. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Study Participants
What is being tested?: bimekizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 2 sitesin 2 countries
Study dates: 17 Mar 2022to 9 Jan 2023
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Study participant must be ≥18 years and ≤65 years of age inclusive, at the time of signing the informed consent
Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests, during the Screening Period and on admission
Study participant has a body temperature between 35.0°C and 37.5°C, inclusive, at Screening and on admission
Body weight minimum of 50 kg for male and 45 kg for female study participants and a maximum of 100 kg for all study participants, and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive) at the Screening Visit
Male or female. Contraception guidelines (as per the standard UCB contraceptive guideline) will be applicable.

Who cannot join

Study participant has a known hypersensitivity to any components of the bimekizumab (and/or an investigational device) as stated in this protocol
Study participant has an active infection or history of infections as follows:
Any active infection (except common cold) within 14 days prior to Screening Visit
A serious infection, defined as requiring hospitalization or iv anti-infectives within 2 months prior to the Screening Visit
A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the study participant. Opportunistic infections are infections caused by uncommon pathogens (eg, pneumocystis jirovecii, cryptococcosis) or unusually severe infections caused by common pathogens (eg, cytomegalovirus, herpes zoster)
Study participant has a history of a positive TB test or evidence of possible TB or latent TB infection at Screening Visit. Refer to Tuberculosis Detection Procedure Guideline for details regarding TB infection status, detection procedures, and the related exclusion criteria

Show all 19Show fewer

Study participants receiving any live (includes attenuated) vaccination within the 8 weeks prior to the Screening Visit (eg, inactivated influenza and pneumococcal vaccines are allowed, but nasal influenza vaccination is not permitted). Live vaccines are not allowed during the study or for 20 weeks after the last dose of the investigational medicinal product (IMP)
Study participant has previously participated in this study or a study participant has previously been assigned to bimekuzimab treatment in any other study
Exposure to 3 or more new chemical entities within 12 months prior to dosing
Current enrollment or past participation within the last 30 days before signing the informed consent form (ICF) in any other clinical study involving an investigational study intervention or any other type of medical research
Study participant has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection. Study participants who have evidence of, or tested positive for hepatitis B or hepatitis C are excluded
Study participant has made a blood donation of a blood loss of more than 400 mL of blood or blood products within 90 days prior to admission (Day -1) or plans to donate blood during the study
Female study participant who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method
Study participant has an alcohol consumption of more than 21 units (males) or 14 units (females) of alcohol per week (1 unit of alcohol is equivalent to 12.5 mL ethanol at room temperature)
Study participant tests positive for alcohol or drugs (urine test) at Screening or Day -1
Vulnerable study participants (eg, participants kept in detention, protected adults under guardianship or trusteeship, and soldiers or participants committed to an institution by governmental or juridical order), employees of the Sponsor or the contract research organization (CRO) with direct involvement in the proposed study or other studies under the direction of the Investigator or the CRO, as well as family members of the employees or the Investigator
Study participant has a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in real-time reverse transcriptase polymerase chain reaction (RT-PCR) on the admission sample
Study participant has clinical signs and symptoms consistent with COVID-19, eg fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the previous 14 days prior to Screening or on admission
Study participant who had severe course of COVID-19 (ie, hospitalization, extracorporal membrane oxygenation, mechanically ventilated)

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

UP0119 2
Glendale, California, 91206

Other trials in United States

Germany1 site

UP0119 1
Berlin

Other trials in Germany

About this study

Official title: An Open-Label, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants

Conditions: Healthy Study Participants
Being tested: bimekizumab
Keywords: UCB4940, BKZ, bimekizumab, Bioequivalence, Auto-injector, Healthy study participants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bimekizumabDrug
Also called BKZ; UCB4940
Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period.

Study groups in NCT05292131
Study group	Role	What they receive
Test	Experimental	Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test). Receives: Drug: bimekizumab
Reference	Other	Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference). Receives: Drug: bimekizumab

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 to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)
AUC is the area under the plasma concentration-time curve from time 0 (Day 1 predose) to infinity.
Measured: Baseline (Day 1 predose) at predefined time points (up to Day 140)
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ)
AUC0-t is the area under the plasma concentration-time curve from time zero (Day 1 predose) to the last quantifiable concentration.
Measured: From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)
Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ)
Cmax is a maximum observed plasma concentration.
Measured: From Baseline (Day 1 predose) at predefined time points (up to Day 140)

Secondary outcomes (4)

Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up
An AE is any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment.
Measured: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up
A SAE is defined as any untoward medical occurrence that at any dose: a. Results in death, b. Is life-threatening, c. Requires inpatient hospitalization or prolongation of existing hospitalization, d. Results in persistent disability/incapacity, e. Is a congenital anomaly/ birth defect, f. Is an important medical event which based on appropriate medical judgment, jeopardized the study participant and required medical or surgical intervention to prevent any of the above.
Measured: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
Apparent Terminal Half-life (t1/2)
Apparent terminal half-life as determined via linear regression (slope=-lamdbaz) of the natural log (ln) concentration versus time, for data points in the terminal phase of the concentration time curve (ln2/lambdaz).
Measured: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ)
tmax is the time to reach maximum plasma concentration.
Measured: From Baseline (Day 1 predose) at predefined time points (up to Day 140)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 20229 Jan 2023

First posted23 Mar 2022
Study start17 Mar 2022
Primary completion9 Jan 2023
Study completion9 Jan 2023

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 Study ParticipantsStudies 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: Single group
Masking: None (open label)
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05292131
Sponsor's protocol ID: UP0119
Status last verified: Mar 2025
First submitted: 14 Mar 2022
Last updated: 10 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Data from Phase 1 trials in Healthy Volunteers is outside of UCB's data sharing policy and is unavailable for sharing.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants
ClinicalTrials.gov ID: NCT05292131
Acronym / sponsor ID: UP0119
Conditions: Healthy Study Participants
Keywords: UCB4940, BKZ, bimekizumab, Bioequivalence, Auto-injector, Healthy study participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: UCB Biopharma SRLIndustry (pharma, biotech, devices)
Study start: 17 Mar 2022 (actual)
Primary completion: 9 Jan 2023 (actual)
Study completion: 9 Jan 2023 (actual)
First posted: 23 Mar 2022 (actual)
Results: Posted 10 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test	Experimental	Drug: bimekizumabStudy participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test).
Reference	Other	Drug: bimekizumabStudy participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Study participant must be ≥18 years and ≤65 years of age inclusive, at the time of signing the informed consent
Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests, during the Screening Period and on admission
Study participant has a body temperature between 35.0°C and 37.5°C, inclusive, at Screening and on admission
Body weight minimum of 50 kg for male and 45 kg for female study participants and a maximum of 100 kg for all study participants, and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive) at the Screening Visit
Male or female. Contraception guidelines (as per the standard UCB contraceptive guideline) will be applicable.

Key exclusion criteria (19 listed)

Study participant has a known hypersensitivity to any components of the bimekizumab (and/or an investigational device) as stated in this protocol
Study participant has an active infection or history of infections as follows:
Any active infection (except common cold) within 14 days prior to Screening Visit
A serious infection, defined as requiring hospitalization or iv anti-infectives within 2 months prior to the Screening Visit
A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the study participant. Opportunistic infections are infections caused by uncommon pathogens (eg, pneumocystis jirovecii, cryptococcosis) or unusually severe infections caused by common pathogens (eg, cytomegalovirus, herpes zoster)

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
bimekizumabAlso: BKZ; UCB4940Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period.	Drug	Reference, Test

Primary outcome

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)
Time frame: Baseline (Day 1 predose) at predefined time points (up to Day 140)
AUC is the area under the plasma concentration-time curve from time 0 (Day 1 predose) to infinity.
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ)
Time frame: From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)
AUC0-t is the area under the plasma concentration-time curve from time zero (Day 1 predose) to the last quantifiable concentration.
Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ)
Time frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Cmax is a maximum observed plasma concentration.

4 secondary outcomes

Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up
Time frame: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up
Time frame: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
Apparent Terminal Half-life (t1/2)
Time frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ)
Time frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)

Results and safety

Results posted to the registry on 10 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bimekizumab-AI-2mL (Test)	60	59
Bimekizumab-AI-2x1mL (Reference)	61	59

Primary outcome: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)

Time frame: Baseline (Day 1 predose) at predefined time points (up to Day 140). Geometric least squares mean (95% Confidence Interval). Unit: days*micrograms/milliliter (days*ug/mL)

Measure	Bimekizumab-AI-2mL (Test) n = 60	Bimekizumab-AI-2x1mL (Reference) n = 59
Value	1223 (1146.1 to 1306.1)	1255 (1174.2 to 1341.1)

Bimekizumab-AI-2mL (Test) vs Bimekizumab-AI-2x1mL (Reference): Geometric Mean Ratio (percentage [%]): 97.50 (90% CI 90.20 to 105.40)

Population analysed: The Pharmacokinetic Set (PKS) was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting pharmacokinetics (PK) during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment.

Primary outcome: Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ)

Time frame: From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140). Geometric least squares mean (95% Confidence Interval). Unit: day*ug/mL

Measure	Bimekizumab-AI-2mL (Test) n = 60	Bimekizumab-AI-2x1mL (Reference) n = 59
Value	1186 (1114.7 to 1262.9)	1223 (1147.3 to 1302.6)

Bimekizumab-AI-2mL (Test) vs Bimekizumab-AI-2x1mL (Reference): Geometric Mean Ratio (%): 97.05 (90% CI 90.10 to 104.55)

Population analysed: The PKS was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting PK during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment.

Primary outcome: Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ)

Time frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140). Geometric least squares mean (95% Confidence Interval). Unit: micrograms/milliliter (ug/mL)

Measure	Bimekizumab-AI-2mL (Test) n = 60	Bimekizumab-AI-2x1mL (Reference) n = 60
Value	35.17 (32.8 to 37.7)	36.55 (34.1 to 39.2)

Bimekizumab-AI-2mL (Test) vs Bimekizumab-AI-2x1mL (Reference): Geometric Mean Ratio (%): 96.21 (90% CI 88.60 to 104.47)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bimekizumab-AI-2mL (Test)	0 of 60 (0%)	11 of 60 (18.3%)	0 of 60
Bimekizumab-AI-2x1mL (Reference)	0 of 61 (0%)	16 of 61 (26.2%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Data from Phase 1 trials in Healthy Volunteers is outside of UCB's data sharing policy and is unavailable for sharing.

Related trials for Healthy Study Participants

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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

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2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing bimekizumab in people with Healthy Study Participants, run by UCB Biopharma SRL at 2 sites in 2 countries.

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 5 inclusion and 19 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 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Germany. 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 10 Apr 2025). 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 to Infinity (AUC) for a Single Dose Bimekizumab (BKZ) (time frame: Baseline (Day 1 predose) at predefined time points (up to Day 140)). 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?

On the ClinicalTrials.gov record for NCT05292131.

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 10 Apr 2025.