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
Overview
- Phase
- Phase 1
- Intervention
- bimekizumab
- Conditions
- Healthy Study Participants
- Sponsor
- UCB Biopharma SRL
- Enrollment
- 121
- Locations
- 2
- Primary Endpoint
- Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
Arms & Interventions
Test
Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test).
Intervention: bimekizumab
Reference
Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference).
Intervention: bimekizumab
Outcomes
Primary Outcomes
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)
Time Frame: Baseline (Day 1 predose) at predefined time points (up to Day 140)
AUC is the area under the 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)
Time Frame: From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)
AUC0-t is the area under the 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 is a maximum observed plasma concentration.
Secondary Outcomes
- 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))
- 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))
- Apparent Terminal Half-life (t1/2)(From Baseline (Day 1 predose) at predefined time points (up to Day 140))
- 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))