PII-080

I. Choi,1 S. Rhee,1 S. Kim,1 I. Jang,1 S. Shin,1 H. Lee,1 K. Yu,1 Y. Koh,2 T. Koo,2 J. Sohn,2 J. Kim2; 1Seoul National University Hospital, Seoul, Korea, Republic of, 2Chong Kun Dang Phamaceutical Corp., Republic of Korea, Gyeonggi-do, Korea, Republic of

BACKGROUND: Darbepoetin alpha (NESP®, manufactured by Kyowa-Hakko-Krin, Japan) has a sustained erythropoietic activity with a longer half-life than conventional recombinant human erythropoietin. CKD-11101 (a biosimilar of NESP® manufactured by Chong Kun Dang Pharm. Korea) is under clinical development. The purpose of this study was to compare the pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles of CKD-11101 with those of NESP® in healthy volunteers.
METHODS: A randomized, double-blind, single-dose, two-sequence, two-period crossover study was performed in 29 subjects, who randomly received one of intravenous CKD-11101 and NESP®, both at 60 μg, in period 1 and the other in period 2 after a 3-week washout. Blood samples for PK and PD analyses were collected up to 264 hours. A non-compartmental analysis was used to calculate the PK and PD parameters. Tolerability was evaluated throughout the study.
RESULTS: The Geometric Mean Ratio (90% Confidential Interval) of CKD-11101 to NESP® for the Cmax and the AUC0-264h were 1.05 (1.03-1.07) and 1.07 (1.04-1.11), respectively. No statistically meaningful differences were noted in the maximum change from baseline in reticulocyte count (Emax) (P = 0.337) or the area under the change from baseline in reticulocyte count-time (AUEC) (P = 0.247); Emax was 1.29 ± 0.50 (mean ± SD) percent points for CKD-11101 and 1.43 ± 0.48 percent points for NESP®, and AUEC was 174.30 ± 84.68 for CKD-11101 and 203.77 ± 75.49 for NESP®, respectively. A total of 26 adverse events occurred and the frequency of occurrence was not significantly different between two treatments. No antibodies were detected in any participants.
CONCLUSION: Intravenous CKD-11101 was tolerated well, and showed a comparable PK, PD, and tolerability profile to that of NESP®.