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



Status:Active, not recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:2/17/2019
Start Date:October 15, 2018
End Date:June 2019

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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

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.


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)
We found this trial at
2
sites
Berlin,
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Berlin,
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Baltimore, Maryland 21225
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Baltimore, MD
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