A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
300
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
Seoul National University Hospital
Seoul, South Korea
RECRUITINGPrimary objective
To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf)
Time frame: up to Day 43
Primary objective
To demonstrate PK similarity in terms of Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Time frame: up to Day 43
Primary objective
To demonstrate PK similarity in terms of Maximum serum concentration (Cmax)
Time frame: up to Day 43
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