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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
696
Subjects will receive a single injection of MSB11456 on Day 1.
Subjects will receive a single injection of US-licensed actemra on Day 1.
Subjects will receive a single injection of EU-approved RoActemra on Day 1.
Research site
Auckland, New Zealand
Research site
Christchurch, New Zealand
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
Time frame: 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
Time frame: Up to Day 48
Maximum Observed Serum Concentration (Cmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: Up to Day 48
Area Under Curve From Tme Zero to 72 Hours After Dosing (AUC 0-72) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: 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
Time frame: Up to Day 48
Time To Reach Maximum Serum Concentration (tmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: Up to Day 48
Time to Last Observed Serum Concentration (tlast) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: Up to Day 48
Apparent Terminal Rate Constant (λz) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: Up to Day 48
Apparent Terminal Half-life (t½) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: Up to Day 48
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Apparent Total Body Clearance of Drug from Serum Following Subcutaneous Administration (CL/F) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: 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
Time frame: Up to Day 48
Immunogenicity as Assessed by Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies (NABs)
Time frame: Up to Day 48