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 intervals (CIs) for C_max, AUC_0–last and AUC_0–∞ were all within 0.8–1.25. No statistically significant differences were noted in the maximum baseline adjusted reticulocyte count or the area under the baseline adjusted reticulocyte count-time between the CKD-11101 and reference drug after IV or SC dose (all p-value>0.05). Both CKD-11101 and reference drug were generally well tolerated.

Discussion

After a single IV or SC dose, the CKD-11101 was well tolerated and showed comparable PK and PD characteristics with reference drug.

Keywords:

• pharmacokinetics
• pharmacodynamics
• biosimilar
• darbepoetin alfa

Acknowledgments

This study was sponsored by a research grant from Chong Kun Dang Pharmaceutical Corp., Seoul, Republic of Korea. The funders had no role in data collection and analysis or preparation of the manuscript. The authors thank the staff of the Seoul National University Hospital Clinical Trials Center for their generous cooperation. Inseung Jeon and Jaeseong Oh and are co-first authors.

Data Sharing Statements

The individual de-identified participant data supporting published results are available with approval from the corresponding author on reasonable request, at any time after publication.

Disclosure

Yu-Kyung Kwon is a full-time employee of Chong Kun Dang Pharmaceutical Corp., Seoul, Republic of Korea. The other authors report no conflicts of interest associated with this work.