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

NCT03707717 | Completed Phase 1 FDA Drug

• 2 other identifiers: UP00332017-004403-48
• Study Type: interventional
• Target: 189
• Locations: 2 countries
• Sites: 2

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.

Conditions

Healthy Volunteers

Keywords

BKZ; UCB4940; Auto-Injector; Healthy Participants

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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.

  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.

  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

  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)

  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)

  From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)

• Apparent terminal half-life (t1/2)

  From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)

• Apparent terminal elimination rate constant (lambdaz)

  From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)

• Total body plasma clearance for BKZ (CL/F)

  From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)

Study Arms (3)

Bimekizumab-SS

EXPERIMENTAL

Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a prefilled syringe.

Drug: Bimekizumab

Bimekizumab-AI

EXPERIMENTAL

Subjects randomized to this arm will receive bimekizumab administered subcutaneously with an auto-injector.

Drug: Bimekizumab

Bimekizumab-TN

EXPERIMENTAL

Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a reference device.

Drug: Bimekizumab

Interventions

Bimekizumab DRUG

Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.

Also known as: BKZ, UCB4940

Bimekizumab-AI; Bimekizumab-SS; Bimekizumab-TN

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (2)

Up0033 002

Baltimore, Maryland, 21225, United States

Location

Up0033 001

Berlin, Germany

Location

MeSH Terms

Interventions

bimekizumab

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 16, 2018
• Study Start: October 15, 2018
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); US (1)