A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects
This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
154
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
CHA Bundang Medical Center
Seongnam, Bundang-gu, South Korea
Chungnam National University Hospital
Daejeon, Jung-gu, South Korea
AUCinf
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: up to Day 253
AUClast
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Time frame: up to Day 253
Cmax
maximum serum concentration (Cmax)
Time frame: up to Day 253
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