A randomized, double-blind, three-arm, parallel group, single-dose phase I study to evaluate the pharmacokinetic similarity between SB12 (a proposed eculizumab biosimilar) and eculizumab (Soliris) in healthy subjects

Objectives: To compare the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity between SB12 (a proposed eculizumab biosimilar) and the reference product (RP) eculizumab (i.e., European Union (EU)-sourced Soliris and United States (US)-sourced Soliris). Materials and methods: In...

Descripción completa

Detalles Bibliográficos
Autores principales: Lee, Hyun A, Jang, Hyerin, Jeong, Deokyoon, Kim, Younsoo, Fuhr, Rainard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dustri-Verlag Dr. Karl Feistle 2022
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097519/
https://www.ncbi.nlm.nih.gov/pubmed/35348111
http://dx.doi.org/10.5414/CP204176

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097519/
https://www.ncbi.nlm.nih.gov/pubmed/35348111
http://dx.doi.org/10.5414/CP204176

Ejemplares similares