Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Department of Clinical Research, Chong Kun Dang, Seoul, Republic of Korea.
Drug Des Devel Ther. 2021 Apr 28;15:1735-1747. doi: 10.2147/DDDT.S303772. eCollection 2021.
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.
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.
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, AUC and AUC 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 -value>0.05). Both CKD-11101 and reference drug were generally well tolerated.
After a single IV or SC dose, the CKD-11101 was well tolerated and showed comparable PK and PD characteristics with reference drug.
达贝泊汀阿尔法（NESP 和 ARANESP）具有比传统重组人促红细胞生成素更长的半衰期和持续的促红细胞生成活性。CKD-11101 正在作为达贝泊汀阿尔法的生物类似药进行临床开发。本研究的目的是比较 CKD-11101 与参比药物在健康受试者中的药代动力学（PK）、药效学（PD）和耐受性特征。
这项研究在健康受试者中进行了两部分。在每个时期，均通过静脉内（IV）或皮下（SC）途径给予 60 μg 的 CKD-11101 和参比药物。
在 IV 或 SC 剂量后，CKD-11101 与参比药物的几何均数比（GMR）及其 C、AUC 和 AUC 的 90%置信区间（CI）均在 0.8-1.25 范围内。在 IV 或 SC 剂量后，最大基线调整网织红细胞计数或基线调整网织红细胞计数时间的 AUC 之间，CKD-11101 与参比药物之间无统计学显著差异（所有 - 值>0.05）。CKD-11101 和参比药物均通常具有良好的耐受性。
单次 IV 或 SC 剂量后，CKD-11101 具有良好的耐受性，并显示出与参比药物相当的 PK 和 PD 特征。
