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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707717
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Bimekizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : June 5, 2019
Actual Study Completion Date : June 5, 2019

Arm Intervention/treatment
Experimental: Bimekizumab-SS
Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a prefilled syringe.
Drug: Bimekizumab
Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.
Other Names:
  • BKZ
  • UCB4940

Experimental: Bimekizumab-AI
Subjects randomized to this arm will receive bimekizumab administered subcutaneously with an auto-injector.
Drug: Bimekizumab
Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.
Other Names:
  • BKZ
  • UCB4940

Experimental: Bimekizumab-TN
Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a reference device.
Drug: Bimekizumab
Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.
Other Names:
  • BKZ
  • UCB4940




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    Tmax is the time to reach maximum plasma concentration.

  3. Apparent terminal half-life (t1/2) [ Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) ]
    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.

  4. Apparent terminal elimination rate constant (lambdaz) [ Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) ]
    The lambdaz is the rate constant of elimination.

  5. Total body plasma clearance for BKZ (CL/F) [ Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) ]
    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.

  6. Volume of distribution for BKZ (Vz/F) [ Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) ]
    Volume of distribution (Vz/F) for BKZ will be calculated as CL/lambdaz.

  7. Time to last quantifiable BKZ plasma concentration (tmin) [ Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) ]
    Tmin is the time to last quantifiable plasma concentration for BKZ.

  8. Incidence of Anti-drug-antibodies (ADABs) [ Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) ]
    Anti-drug-antibodies (ADABs) will be determined from blood samples taken at predefined timepoints.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707717


Locations
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United States, Maryland
Up0033 002
Baltimore, Maryland, United States, 21225
Germany
Up0033 001
Berlin, Germany
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03707717    
Other Study ID Numbers: UP0033
2017-004403-48 ( EudraCT Number )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
BKZ
UCB4940
Auto-Injector
Healthy Participants