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This study aims to compare the PK/PD of a single injection of investigational Medicinal Product (IMP) MSB11456, US licensed Actemra and EU approved RoActemra in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSB11456 | Experimental |
| |
| US-licensed Actemra | Active Comparator |
| |
| EU-approved RoActemra | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSB11456 | Drug | Subjects will receive a single injection of MSB11456 on Day 1. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of MSB11456, US-licensed Actemra, and EU-approved RoActemra | Up to Day 48 | |
| Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MSB11456, US-licensed Actemra, and EU-approved RoActemra | Up to Day 48 | |
| Maximum Observed Serum Concentration (Cmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra | Up to Day 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve From Tme Zero to 72 Hours After Dosing (AUC 0-72) of MSB11456, US-licensed Actemra, and EU-approved RoActemra | Up to Day 48 | |
| Percentage of Area Under Curve From Zero to Infinity (AUC0-∞) Obtained by Extrapolation (AUC extra%) of MSB11456, US-licensed Actemra, and EU-approved RoActemra |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Fresenius Kabi SwissBioSim GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Auckland | New Zealand | ||||
| Research site |
| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| US-licensed Actemra |
| Drug |
Subjects will receive a single injection of US-licensed actemra on Day 1. |
|
| EU-approved RoActemra | Drug | Subjects will receive a single injection of EU-approved RoActemra on Day 1. |
|
| Up to Day 48 |
| Time To Reach Maximum Serum Concentration (tmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra | Up to Day 48 |
| Time to Last Observed Serum Concentration (tlast) of MSB11456, US-licensed Actemra, and EU-approved RoActemra | Up to Day 48 |
| Apparent Terminal Rate Constant (λz) of MSB11456, US-licensed Actemra, and EU-approved RoActemra | Up to Day 48 |
| Apparent Terminal Half-life (t½) of MSB11456, US-licensed Actemra, and EU-approved RoActemra | Up to Day 48 |
| Apparent Total Body Clearance of Drug from Serum Following Subcutaneous Administration (CL/F) of MSB11456, US-licensed Actemra, and EU-approved RoActemra | Up to Day 48 |
| Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Injection Site Reactions, Laboratory Variables, Vital Signs and Electrocardiogram (ECG) Measurements | Up to Day 48 |
| Immunogenicity as Assessed by Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies (NABs) | Up to Day 48 |
| Christchurch |
| New Zealand |