This study is designed to demonstrate PK similarity of the proposed biosimilar test product CT-P52 and the reference product, US-licensed Taltz.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
218
80 mg (single dose), SC injection via PFS
Inje University Busan Paik Hospital
Busan, Busanjin-gu, South Korea
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
AUC0-inf
Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Time frame: Day 85
Cmax
PK similarity demonstration in terms of maximum serum concentration
Time frame: Day 85
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Seoul National University Hospital
Seoul, South Korea