QL0902, a proposed etanercept biosimilar: pharmacokinetic and immunogenicity profile to its reference product in healthy Chinese male subjects.
Expert Opin Biol Ther
; 21(1): 105-110, 2021 01.
Article
en En
| MEDLINE
| ID: mdl-32200659
ABSTRACT
Objectives:
To study the pharmacokinetics, safety and immunogenicity of Recombinant Human Tumor Necrosis Factor-α Receptor II IgG Fc Fusion Protein for Injection (QL0902) and evaluate the pharmacokinetic similarity between QL0902 and reference Etanercept in healthy male subjects.Methods:
A randomized, double-blinded, single-dose, two-period, two-sequence and crossover study was conducted in healthy males. Sixty-eight subjects were randomized at 11 ratio to receive a single 50-mg subcutaneous injection of QL0902 or reference Etanercept. The statistical analysis was conducted by SAS Enterprise Guide statistical software.Results:
The main pharmacokinetic parameters of QL0902 were as follows AUC0-∞ was 461861.60 ± 126861.42 (h*ng/mL), AUC0-t was 453304.68 ± 124424.94 (h*ng/mL), Cmax was (2634.03 ± 833.82)ng/mL; The main pharmacokinetic parameters of reference Etanercept were as follows AUC0-∞ was 537977.72 ± 153295.70 (h*ng/mL), AUC0-t was 528817.19 ± 150910.05 (h*ng/mL), Cmax was (2874.21 ± 822.31) ng/mL.Conclusions:
After a single subcutaneous injection of QL0902 and reference Etanercept, the 90% confidence intervals of the ratios of AUC0-∞, AUC0-t, Cmax of healthy subjects were respectively 82.76% to 89.15%, 82.66% to 89.00%, 87.30% to 93.95%, which were between 80.00% and 125.00%. It indicts that their pharmacokinetic characteristics were similar. No serious adverse events occurred and the immunogenicity of QL0902 was lower. Trial Registration The trial is registered at www.chictr.org.cn (ChiCTR1900023 437).Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Biosimilares Farmacéuticos
Tipo de estudio:
Clinical_trials
Límite:
Humans
/
Male
País/Región como asunto:
Asia
Idioma:
En
Revista:
Expert Opin Biol Ther
Asunto de la revista:
BIOLOGIA
/
TERAPEUTICA
Año:
2021
Tipo del documento:
Article
País de afiliación:
China