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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BKZ
UCB4940
Auto-Injector
Healthy Participants
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-10-16
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)

Primary outcomes:
measure: Maximum observed bimekizumab (BKZ) plasma drug concentration (Cmax)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Area under the BKZ plasma concentration-time curve from time zero to last quantifiable concentration (AUCt)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Area under the BKZ plasma concentration-time curve from time zero to infinity (AUC)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Percentage of subjects with at least one Adverse Event (AE) from first bimekizumab (BKZ) dose up to Safety Follow Up
timeFrame: From Baseline to Safety Follow Up (up to Day 140)
measure: Percentage of subjects with at least one Serious Adverse Event (SAE) from first bimekizumab (BKZ) dose up to Safety Follow Up
timeFrame: From Baseline to Safety Follow Up (up to Day 140)
Secondary outcomes:
measure: Percentage of the AUC extrapolated from the last quantifiable BKZ plasma concentration (%AUCex)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Time of occurrence of the maximum observed BKZ plasma drug concentration (tmax)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Apparent terminal half-life (t1/2)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Apparent terminal elimination rate constant (lambdaz)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Total body plasma clearance for BKZ (CL/F)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Volume of distribution for BKZ (Vz/F)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Time to last quantifiable BKZ plasma concentration (tmin)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Incidence of Anti-drug-antibodies (ADABs)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Up0033 002
state: Maryland
city: Berlin
country: Germany
facility: Up0033 001
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: