Phase 1
Completed N=121
A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants
Healthy Study Participants
Source: ClinicalTrials.gov NCT05292131 ↗
Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ) — 1223; 1255 days*micrograms/milliliter (days*ug/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ) |
1223; 1255 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ) |
1186; 1223 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ) |
35.17; 36.55 | — |
| SECONDARY Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up |
43.3; 49.2 | — |
| SECONDARY Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up |
0; 0 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) |
24.65; 24.38 | — |
| SECONDARY Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ) |
6.962; 5.979 | — |
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 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 invol
Data sourced from ClinicalTrials.gov (NCT05292131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.