Healthy VolunteersPhase 1NCT03707717
A Study to Compare the Blood Level of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-injector in Adult Healthy Volunteer Participants
A Phase 1 study testing Bimekizumab in people with Healthy Volunteers, run by UCB Biopharma S.P.R.L. at 2 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the pharmakokinetics (PK), safety, tolerability, and immunogenicity of bimekizumab (BKZ) when administered subcutaneously (sc) via 3 different BKZ delivery devices in healthy 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?
- Bimekizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Oct 2018to 5 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 is male or female aged >=18 years and <=55 years at Screening Visit
- Participant must be in good health (physically and mentally) as determined by the Investigator based on medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory screening tests during the Screening Period
- Participant has a body mass index (BMI) of 18-32 kg/m2 and a minimum body weight of 50 kg for male participants and 45 kg for female participants, and a maximum body weight of 100 kg for all participants
- Participant is willing to abstain from alcohol-, tobacco-, and caffeine-containing products for 48 h prior to admission into the clinic and during the entire in-clinic stay
Who cannot join
- Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections
- Participant has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening Visit
- Participant has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- Female 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
- Participants receiving any live (includes attenuated) vaccination within the 8 weeks prior to 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 IMP
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study
- Participant has active neoplastic disease or history of neoplastic disease within 5 years of Screening Visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open-Label, Multicenter, Randomized, Parallel-Group, 3-Arm, Single-Dose Bioequivalence Study of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-Injector in Adult Healthy Participants
The purpose of the study is to evaluate the pharmakokinetics (PK), safety, tolerability, and immunogenicity of bimekizumab (BKZ) when administered subcutaneously (sc) via 3 different BKZ delivery devices in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- Bimekizumab
- Keywords
- BKZ, UCB4940, Auto-Injector, Healthy 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
Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.
| Study group | Role | What they receive |
|---|---|---|
| Bimekizumab-SS | Experimental | Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a prefilled syringe. Receives: Drug: Bimekizumab |
| Bimekizumab-AI | Experimental | Subjects randomized to this arm will receive bimekizumab administered subcutaneously with an auto-injector. Receives: Drug: Bimekizumab |
| Bimekizumab-TN | Experimental | Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a reference device. Receives: Drug: Bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed bimekizumab (BKZ) plasma drug concentration (Cmax)
The Cmax is the maximum plasma drug concentration of BKZ observed from pharmacokinetic samples taken at predefined time points.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Area under the BKZ plasma concentration-time curve from time zero to last quantifiable concentration (AUCt)
The AUCt is the area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUCt) of BKZ as determined using the linear trapezoidal rule.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Area under the BKZ plasma concentration-time curve from time zero to infinity (AUC)
The area under the plasma concentration-time curve from time zero to infinity (AUC) of BKZ is calculated as AUC=AUCt+Clast/lambdaz, where Clast is the last quantifiable plasma concentration and λz is the apparent terminal elimination rate constant.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Percentage of subjects with at least one Adverse Event (AE) from first bimekizumab (BKZ) dose up to Safety Follow Up
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
Measured: From Baseline to Safety Follow Up (up to Day 140)
Percentage of subjects with at least one Serious Adverse Event (SAE) from first bimekizumab (BKZ) dose up to Safety Follow Up
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Is a congenital anomaly or birth defect
- Is as infection that requires treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Measured: From Baseline to Safety Follow Up (up to Day 140)
Secondary outcomes (8)
Percentage of the AUC extrapolated from the last quantifiable BKZ plasma concentration (%AUCex)
The percentage of the AUC extrapolated from the last quantifiable BKZ plasma concentration (Clast) is computed from plasma concentrations of pharmacokinetic samples taken at predefined time points.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Time of occurrence of the maximum observed BKZ plasma drug concentration (tmax)
Tmax is the time to reach maximum plasma concentration.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Apparent terminal half-life (t1/2)
Apparent terminal half-life, reported in units of days, as determined via simple linear regression (slope=-lambdaz) of natural log (ln) concentration versus time for data points in the terminal phase of the concentration-time curve. t1/2 is calculated as ln2/lambdaz.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Apparent terminal elimination rate constant (lambdaz)
The lambdaz is the rate constant of elimination.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Total body plasma clearance for BKZ (CL/F)
The total body clearance (CL/F) for BKZ will be calculated as Dose/AUC. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Volume of distribution for BKZ (Vz/F)
Volume of distribution (Vz/F) for BKZ will be calculated as CL/lambdaz.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Time to last quantifiable BKZ plasma concentration (tmin)
Tmin is the time to last quantifiable plasma concentration for BKZ.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Incidence of Anti-drug-antibodies (ADABs)
Anti-drug-antibodies (ADABs) will be determined from blood samples taken at predefined timepoints.
Measured: From Baseline (Day 1 pre-dose) 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.
- First posted16 Oct 2018
- Study start15 Oct 2018
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707717
- Sponsor's protocol ID
- UP0033
- Other IDs
- 2017-004403-48, 2017
- Status last verified
- Jun 2020
- First submitted
- 12 Oct 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Randomized, Parallel-Group, 3-Arm, Single-Dose Bioequivalence Study of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-Injector in Adult Healthy Participants
- ClinicalTrials.gov ID
- NCT03707717
- Acronym / sponsor ID
- UP0033
- Conditions
- Healthy Volunteers
- Keywords
- BKZ, UCB4940, Auto-Injector, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
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 the study is to evaluate the pharmakokinetics (PK), safety, tolerability, and immunogenicity of bimekizumab (BKZ) when administered subcutaneously (sc) via 3 different BKZ delivery devices in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bimekizumab-SS | Experimental | Drug: BimekizumabSubjects randomized to this arm will receive bimekizumab administered subcutaneously with a prefilled syringe. |
| Bimekizumab-AI | Experimental | Drug: BimekizumabSubjects randomized to this arm will receive bimekizumab administered subcutaneously with an auto-injector. |
| Bimekizumab-TN | Experimental | Drug: BimekizumabSubjects randomized to this arm will receive bimekizumab administered subcutaneously with a reference device. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant is male or female aged >=18 years and <=55 years at Screening Visit
- Participant must be in good health (physically and mentally) as determined by the Investigator based on medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory screening tests during the Screening Period
- Participant has a body mass index (BMI) of 18-32 kg/m2 and a minimum body weight of 50 kg for male participants and 45 kg for female participants, and a maximum body weight of 100 kg for all participants
- Participant is willing to abstain from alcohol-, tobacco-, and caffeine-containing products for 48 h prior to admission into the clinic and during the entire in-clinic stay
Key exclusion criteria (7 listed)
- Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections
- Participant has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening Visit
- Participant has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- Female 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
- Participants receiving any live (includes attenuated) vaccination within the 8 weeks prior to 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 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 |
|---|---|---|
| BimekizumabAlso: BKZ, UCB4940Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period. | Drug | Bimekizumab-AI, Bimekizumab-SS, Bimekizumab-TN |
Primary outcome
Maximum observed bimekizumab (BKZ) plasma drug concentration (Cmax)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
The Cmax is the maximum plasma drug concentration of BKZ observed from pharmacokinetic samples taken at predefined time points.
Area under the BKZ plasma concentration-time curve from time zero to last quantifiable concentration (AUCt)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
The AUCt is the area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUCt) of BKZ as determined using the linear trapezoidal rule.
Area under the BKZ plasma concentration-time curve from time zero to infinity (AUC)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
The area under the plasma concentration-time curve from time zero to infinity (AUC) of BKZ is calculated as AUC=AUCt+Clast/lambdaz, where Clast is the last quantifiable plasma concentration and λz is the apparent terminal elimination rate constant.
Percentage of subjects with at least one Adverse Event (AE) from first bimekizumab (BKZ) dose up to Safety Follow Up
Time frame: From Baseline to Safety Follow Up (up to Day 140)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
Percentage of subjects with at least one Serious Adverse Event (SAE) from first bimekizumab (BKZ) dose up to Safety Follow Up
Time frame: From Baseline to Safety Follow Up (up to Day 140)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
8 secondary outcomes
Percentage of the AUC extrapolated from the last quantifiable BKZ plasma concentration (%AUCex)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Time of occurrence of the maximum observed BKZ plasma drug concentration (tmax)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Apparent terminal half-life (t1/2)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Apparent terminal elimination rate constant (lambdaz)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Total body plasma clearance for BKZ (CL/F)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Volume of distribution for BKZ (Vz/F)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Time to last quantifiable BKZ plasma concentration (tmin)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Incidence of Anti-drug-antibodies (ADABs)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 (UCB)
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 Volunteers, run by UCB Biopharma S.P.R.L. 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 4 inclusion and 7 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 16 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum observed bimekizumab (BKZ) plasma drug concentration (Cmax) (time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)). The study lists 5 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 16 Jun 2020.