This is a study to confirm the relative bioequivalence of sonelokimab administered subcutaneously via a prefilled syringe (PFS) or an autoinjector (AI) in healthy adult volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
120
sonelokimab 120 mg administered subcutaneously via a PFS
sonelokimab 120 mg administered subcutaneously via an AI
Clinical Site
London, United Kingdom
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of maximum concentration (Cmax)
Time frame: 64 days
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of area under the time concentration curve to infinite time (AUC0-inf)
Time frame: 64 days
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of area under the time concentration curve from time zero to timepoint with last measurable concentration (AUC0-t)
Time frame: 64 days
Assessment of safety and tolerability
To assess the safety and tolerability of AI and PFS administered sonelokimab by treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: 64 days
Evaluation of the impact of injection site location on PK
Evaluation of the impact of injection site location on PK by capturing the relative bioavailability (F%) for thigh injection of sonelokimab compared to abdomen
Time frame: 64 days
Evaluation of the impact of injection site location on PK
Evaluation of the impact of injection site location on PK by capturing the relative bioavailability (F%) for upper-arm injection of sonelokimab compared to abdomen
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Time frame: 64 days
Evaluation of the impact of injection site location on PK
Evaluation of the impact of injection site location on PK by capturing the relative bioavailability (F%) for thigh injection of sonelokimab compared to upper arm
Time frame: 64 days
Immunogenicity of sonelokimab
Description of the prevalence of antidrug antibodies (ADAs)
Time frame: 64 days