A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants

Healthy Study Participants Clinical Trial

Official title:

An Open-Label, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292131
• Other study ID #: UP0119
• Status: Completed
• Phase: Phase 1
• Start date: March 17, 2022
• Est. completion date: January 9, 2023

Study information

• Verified date: December 2023
• 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), safety and tolerability of a single subcutaneous (sc) dose of bimekizumab (BKZ) when administered using bimekizumab-autoinjector (AI)-2mL presentation versus bimekizumab-AI-2x1mL presentation in healthy study participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• 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 Period and on admission

• Study participant has a body temperature between 35.0°C and 37.5°C, inclusive, at Screening 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

• Male or female. Contraception guidelines (as per the standard UCB contraceptive guideline) will be applicable.

Exclusion Criteria:

• Study participant has a known hypersensitivity to any components of the bimekizumab (and/or an investigational device) as stated in this protocol

• Study participant has an active infection or history of infections as follows:

• Any active infection (except common cold) within 14 days prior to Screening Visit

• A serious infection, defined as requiring hospitalization or iv anti-infectives within 2 months prior to the Screening Visit

• 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 TB test or evidence of possible TB or latent TB infection at Screening Visit. Refer to Tuberculosis Detection Procedure Guideline for details regarding TB infection status, detection procedures, and the related exclusion criteria

• 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 last dose of the investigational medicinal product (IMP)

• Study participant has previously participated in this study or a study participant has previously been assigned to bimekuzimab treatment in any other study

• Exposure to 3 or more new chemical entities within 12 months prior to dosing

• Current enrollment or past participation within the last 30 days before signing the informed consent form (ICF) in any other clinical study involving an investigational study intervention or any other type of medical research

• 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 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

• Female study 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

• Study participant has an alcohol consumption of more than 21 units (males) or 14 units (females) of alcohol per week (1 unit of alcohol is equivalent to 12.5 mL ethanol at room temperature)

• Study participant tests positive for alcohol or drugs (urine test) at Screening or Day -1

• Vulnerable study participants (eg, participants kept in detention, protected adults under guardianship or trusteeship, and soldiers or participants committed to an institution by governmental or juridical order), employees of the Sponsor or the contract research organization (CRO) with direct involvement in the proposed study or other studies under the direction of the Investigator or the CRO, as well as family members of the employees or the Investigator

• 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 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 (BKZ) administered subcutaneously in the Treatment Period.

Locations

Country	Name	City	State
Germany	UP0119 1	Berlin
United States	UP0119 2	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  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	Time Frame: 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)	t1/2: Apparent terminal half-life as determined via linear regression (slope=-lamdbaz) of the natural log (ln) concentration versus time, for data points in the terminal phase of the concentration time curve (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)