A Randomized, Double-blinded, Active Controlled Crossover Clinical Trial to Investigate PK, PD and Safety of GBPD002

Summary

Erythropoietin (EPO) biosimilarity for GBPD002 (test candidate) and Eprex® (comparator) has been evaluated by comparing the pharmacokinetic (PK) and pharmacodynamic (PD) properties following subcutaneous injection in human subjects. This was a randomized, double-blind, two-sequence, crossover study. Subjects were randomly assigned and received a dose (4,000 IU) of either the test or comparator EPO. The subjects received the alternative formulation after the wash out period (4 weeks) of the first administration. The primary PK parameters, viz., maximum observed concentration (Cmax) and area under the curve extrapolated to infinity (AUC00-inf), were calculated with the serum EPO concentrations from blood samples and were found comparable for both formulations. The geometric mean ratios (@90% CI) of the Cmax and AUCinf were 1.16 and 0.89, respectively, which were within the regulatory range of 0.80-1.25. The reticulocyte, hematocrit, hemoglobin and red blood cell counts were measured as PD markers. The time-matched serum EPO concentrations and PD markers denoted a counterclockwise hysteresis, and thereby suggesting a time delay between the observed concentration and the response. ANOVA derived P-values (all were greater than 0.05) for the effectors clearly revealed the similarity between effects on PD markers for both formulations. Both formulations were found tolerated well, and anti-drug antibodies were not observed. Thus, the two formulations are projected to be used interchangeably in clinical settings.

Timeline

Start

2021-10-16

Primary completion

2021-11-14

Completion

2021-12-16

Drugs

Indications