A Bioequivalence Study of Bimekizumab Given as 1x2ml or 2x1ml Subcutaneous Injection Using an Autoinjector in Healthy Study Participants

Sponsor

UCB Biopharma SRL (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05292131

Collaborator

(none)

120

Enrollment

Locations

Arms

9.5

Anticipated Duration (Months)

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Study Participants	Drug: bimekizumab	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Mar 17, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test).	Drug: bimekizumab Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period. Other Names: BKZ; UCB4940
Other: Reference Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference).	Drug: bimekizumab Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period. Other Names: BKZ; UCB4940

Arm

Intervention/Treatment

Experimental: Test

Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test).

Drug: bimekizumab

Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period.

Other Names:

BKZ; UCB4940

Other: Reference

Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference).

Drug: bimekizumab

Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period.

Other Names:

BKZ; UCB4940

Outcome Measures

Primary Outcome Measures

Area under the plasma concentration-time curve from time zero to infinity (AUC) for a single dose bimekizumab (BKZ) [Baseline (Day 1 predose) at predefined time points (up to Day 140)]
AUC: Area under the bimekizumab plasma concentration-time curve from time 0 (Day 1 predose) to infinity
Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUC0-t) for a single dose bimekizumab (BKZ) [From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)]
AUC0-t: Area under the bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to the last quantifiable concentration
Maximum plasma concentration (Cmax) for a single dose bimekizumab (BKZ) [Time Frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)]
Cmax: Maximum observed plasma concentration

Secondary Outcome Measures

Percentage of participants with at least one treatment-emergent adverse event (TEAE) from Baseline to end of Safety Follow-Up [From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)]
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.
Percentage of participants with at least one treatment-emergent serious adverse event (SAE) from Baseline to end of Safety Follow-Up [From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)]
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
Apparent terminal half-life (t1/2) [From Baseline (Day 1 predose) at predefined time points (up to Day 140)]
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).
Time of occurrence of the maximum observed concentration (tmax) of a single dose bimekizumab (BKZ) [From Baseline (Day 1 predose) at predefined time points (up to Day 140)]
tmax: time to reach maximum plasma concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 bimekizumab 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 10 mL ethanol, for example 330 mL of 5% alcohol by volume beer = 1.7 units; 125 mL of 12% wine = 1.5 units: 50 mL of spirits = 2 units]
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)