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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonelokimab via a PFS | Experimental |
| |
| Sonelokimab via an AI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonelokimab | Drug | sonelokimab 120 mg administered subcutaneously via a PFS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 64 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 64 days |
| Evaluation of the impact of injection site location on PK |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | London | United Kingdom |
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| Sonelokimab |
| Drug |
sonelokimab 120 mg administered subcutaneously via an AI |
|
Evaluation of the impact of injection site location on PK by capturing the relative bioavailability (F%) for thigh injection of sonelokimab compared to abdomen |
| 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 | 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 | 64 days |
| Immunogenicity of sonelokimab | Description of the prevalence of antidrug antibodies (ADAs) | 64 days |
| ID | Term |
|---|---|
| C000720946 | sonelokimab |
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