A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants

Healthy Study Participants Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04255862
• Other study ID #: UP0068
• Secondary ID: 2019-002378-30
• Status: Terminated
• Phase: Phase 1
• Start date: February 12, 2020
• Est. completion date: April 26, 2021

Study information

• Verified date: August 2021
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Study Participants

Intervention

Drug:
• Bimekizumab
Study participants will receive a single-dose of bimekizumab administered subcutaneously in the Treatment Period.

Locations

Country	Name	City	State
Germany	Up0068 001	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve from time zero to infinity (AUC) for a single dose bimekizumab (BKZ)	AUC: Area under the bimekizumab plasma concentration-time curve from time 0 (Day 1 predose) to infinity	Baseline (Day 1 predose) at predefined time points (up to Day 140)
Primary	Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUC0-t) for a single dose bimekizumab (BKZ)	AUC0-t: Area under the bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to the last quantifiable concentration	From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)
Primary	Maximum plasma concentration (Cmax) for a single dose bimekizumab (BKZ)	Cmax: Maximum observed plasma concentration	From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Secondary	Percentage of participants with at least one treatment-emergent adverse event (TEAE) from Baseline to end of 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 (Day 1) to end of Safety Follow-Up (up to Day 140)
Secondary	Percentage of participants with at least one treatment-emergent serious adverse event (SAE) from Baseline to end of 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 an 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 (Day 1) to end of Safety Follow-Up (up to Day 140)
Secondary	Apparent terminal half-life (t1/2)	Apparent terminal half-life, reported in units of days, as determined via simple linear regression (slope=-lambdaz) of natural log (ln) concentration versus time for data points in the terminal phase of the concentration-time curve. t1/2 is calculated as ln2/lambdaz.	From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Secondary	Time of occurrence of the maximum observed concentration (tmax) of a single dose bimekizumab (BKZ)	tmax: time to reach maximum plasma concentration	From Baseline (Day 1 predose) at predefined time points (up to Day 140)