Comparison of Pharmacokinetic, Pharmacodynamic and Tolerability Profiles of CKD-11101, Darbepoetin Alfa (NESP^®) Biosimilar, to Those of NESP^® After a Single Subcutaneous or Intravenous Administration to Healthy Subjects.

ABSTRACT:

Introduction

Darbepoetin alfa (NESP^® and ARANESP^®) has a sustained erythropoietic activity with a longer half-life than conventional recombinant human erythropoietin. CKD-11101 is under clinical development as a biosimilar of darbepoetin alfa. The purpose of this study was to compare the pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles of CKD-11101 with those of reference drug in healthy subjects.

Methods

This study was performed in two parts for healthy subjects. In each period, CKD-11101 and reference, both at 60 μg, were administered via intravenous (IV) or subcutaneous (SC) route of administration.

Results

After both IV or SC dose, the geometric mean ratio (GMR) of CKD-11101 to reference drug and its 90% confidence interv

SUBMITTER: Jeon I 

PROVIDER: S-EPMC8089108 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature