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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707717
• Other study ID #: UP0033
• Secondary ID: 2017-004403-48
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2018
• Est. completion date: June 5, 2019

Study information

• Verified date: June 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Bimekizumab
Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.

Locations

Country	Name	City	State
Germany	Up0033 001	Berlin
United States	Up0033 002	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Primary	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.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Primary	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 ?z is the apparent terminal elimination rate constant.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Primary	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.	From Baseline to Safety Follow Up (up to Day 140)
Primary	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	From Baseline to Safety Follow Up (up to Day 140)
Secondary	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.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Secondary	Time of occurrence of the maximum observed BKZ plasma drug concentration (tmax)	Tmax is the time to reach maximum plasma concentration.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Secondary	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.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Secondary	Apparent terminal elimination rate constant (lambdaz)	The lambdaz is the rate constant of elimination.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Secondary	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.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Secondary	Volume of distribution for BKZ (Vz/F)	Volume of distribution (Vz/F) for BKZ will be calculated as CL/lambdaz.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Secondary	Time to last quantifiable BKZ plasma concentration (tmin)	Tmin is the time to last quantifiable plasma concentration for BKZ.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Secondary	Incidence of Anti-drug-antibodies (ADABs)	Anti-drug-antibodies (ADABs) will be determined from blood samples taken at predefined timepoints.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)