Clinical trial NCT04255862: A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants
Official title: An Open-Label, Single-Center, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Study Participants
Keywords: UCB4940
Bimekizumab
Bioequivalence
Auto-injector
Healthy study participants
Safety-syringe
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to compare the pharmacokinetics (PK) of bimekizumab when administered subcutaneously (sc) as 1x2 mL versus 2x1 mL, using a bimekizumab-safety syringe presentation or bimekizumab-auto-injector presentation, in healthy study participants.


Eligibility criteria: Inclusion Criteria:

* Study participant must be ≥18 years and ≤65 years of age inclusive, at the time of signing the informed consent
* Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests, during the Screening Visit and on admission
* Body weight minimum of 50 kg for male and 45 kg for female study participants and a maximum of 100 kg for all study participants, and body mass index (BMI) within the range 18 to 32 kg/m\^2 (inclusive) at the Screening Visit

Exclusion Criteria:

* Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
* Study participant has a known hypersensitivity to any excipients of bimekizumab (and/or an investigational device) as stated in this protocol
* Study participant has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, peripheral arterial disease sufficient to cause symptoms, and/or requires therapy to maintain stable status
* Study participant has an active infection or history of infections as follows:

  1. Any active infection (except common cold) within 14 days prior to the Screening Visit
  2. A serious infection, defined as requiring hospitalization or iv anti-infectives within 2 months prior to the Screening Visit
  3. A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the study participant. Opportunistic infections are infections caused by uncommon pathogens (eg, pneumocystis jirovecii, cryptococcosis) or unusually severe infections caused by common pathogens (eg, cytomegalovirus, herpes zoster)
* Study participant has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at the Screening Visit
* Study participant has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection. Study participants who have evidence of, or tested positive for hepatitis B or hepatitis C are excluded
* Study participant has 12-lead ECG with changes considered to be clinically significant (eg, QT interval corrected using Fridericia's formula \[QTcF\] \>450 ms, bundle branch block, or evidence of myocardial ischemia) at the Screening Visit or on Day -1
* Study participant has active neoplastic disease or history of neoplastic disease within 5 years of the 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)
* Study participants receiving any live (includes attenuated) vaccination within the 8 weeks prior to the 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 dose of the investigational medicinal product (IMP)
* Study participant has previously participated in this study or the study participant has previously been assigned to treatment in a study of the medication under investigation in this study
* Study participant has participated in another study of an IMP (and/or an investigational device) within the previous 90 days or 5 half-lives, whichever is longer, prior to IMP administration
* Study participant has made a blood donation of a blood loss of more than 400 mL of blood or blood products within 90 days prior to admission (Day -1) or plans to donate blood during the study
* Study participant has a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in real-time reverse transcriptase polymerase chain reaction (RT-PCR) on the admission sample
* Study participant has clinical signs and symptoms consistent with coronavirus disease 2019 (COVID-19), eg fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the previous 14 days prior to Screening or on admission
* Study participant who had severe course of COVID-19 (ie, hospitalization, extracorporal membrane oxygenation, mechanically ventilated)

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)
timeFrame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ)
timeFrame: From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)
measure: Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ)
timeFrame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Secondary outcomes:
measure: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up
timeFrame: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
measure: Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up
timeFrame: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
measure: Apparent Terminal Half-life (t1/2)
timeFrame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
measure: Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ)
timeFrame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Up0068 001
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: