- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03707717
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
June 12, 2020 updated by: UCB Biopharma S.P.R.L.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
189
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany
- Up0033 001
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Maryland
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Baltimore, Maryland, United States, 21225
- Up0033 002
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Bimekizumab-SS
Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a prefilled syringe.
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Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.
Other Names:
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Experimental: Bimekizumab-AI
Subjects randomized to this arm will receive bimekizumab administered subcutaneously with an auto-injector.
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Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.
Other Names:
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Experimental: Bimekizumab-TN
Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a reference device.
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Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum observed bimekizumab (BKZ) plasma drug concentration (Cmax)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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The Cmax is the maximum plasma drug concentration of BKZ observed from pharmacokinetic samples taken at predefined time points.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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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)
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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.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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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)
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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.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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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)
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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.
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From Baseline to Safety Follow Up (up to Day 140)
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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)
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A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
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From Baseline to Safety Follow Up (up to Day 140)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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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)
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Tmax is the time to reach maximum plasma concentration.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Apparent terminal half-life (t1/2)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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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.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Apparent terminal elimination rate constant (lambdaz)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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The lambdaz is the rate constant of elimination.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Total body plasma clearance for BKZ (CL/F)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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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.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Volume of distribution for BKZ (Vz/F)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Volume of distribution (Vz/F) for BKZ will be calculated as CL/lambdaz.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Time to last quantifiable BKZ plasma concentration (tmin)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Tmin is the time to last quantifiable plasma concentration for BKZ.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Incidence of Anti-drug-antibodies (ADABs)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Anti-drug-antibodies (ADABs) will be determined from blood samples taken at predefined timepoints.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2018
Primary Completion (Actual)
June 5, 2019
Study Completion (Actual)
June 5, 2019
Study Registration Dates
First Submitted
October 12, 2018
First Submitted That Met QC Criteria
October 12, 2018
First Posted (Actual)
October 16, 2018
Study Record Updates
Last Update Posted (Actual)
June 16, 2020
Last Update Submitted That Met QC Criteria
June 12, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UP0033
- 2017-004403-48 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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