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

NCT ID: NCT03707717

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2019-06-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Bimekizumab-SS

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

Group Type: EXPERIMENTAL

Bimekizumab

Intervention Type: DRUG

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

Bimekizumab-AI

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

Group Type: EXPERIMENTAL

Bimekizumab

Intervention Type: DRUG

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

Bimekizumab-TN

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

Group Type: EXPERIMENTAL

Bimekizumab

Intervention Type: DRUG

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

Interventions

Bimekizumab

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

Intervention Type: DRUG

Other Intervention Names

BKZ; UCB4940

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Up0033 002

Baltimore, Maryland, United States

Up0033 001

Berlin, , Germany

Countries

United States; Germany

Other Identifiers

2017-004403-48

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UP0033

Identifier Type: -

Identifier Source: org_study_id