Cargando…
A randomized, double‐blind, single‐dose, three‐arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris(®)) in healthy male subjects
OBJECTIVES: ABP 959 is a proposed biosimilar to eculizumab, a monoclonal antibody targeting the human C5 complement protein. The objective of this randomized, double‐blind, three‐arm, study was to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity of ABP 959 relative to the eculizu...
Autores principales: | Chow, Vincent, Pan, Jean, Chien, David, Mytych, Daniel T., Hanes, Vladimir |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7384155/ https://www.ncbi.nlm.nih.gov/pubmed/32196749 http://dx.doi.org/10.1111/ejh.13411 |
Ejemplares similares
-
P815: PHARMACOKINETIC AND PHARMACODYNAMIC SIMILARITY OF ABP 959 AND ECULIZUMAB REFERENCE PRODUCT: UNBOUND ECULIZUMAB AND CH50 FROM THE RANDOMIZED, DOUBLE-BLIND, SINGLE-DOSE STUDY IN HEALTHY VOLUNTEERS
por: Hanes, V., et al.
Publicado: (2022) -
Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product
por: Hutterer, Katariina M., et al.
Publicado: (2021) -
Functional similarity of ABP 959 and eculizumab in simulated serum models of aHUS and NMOSD
por: McBride, Helen J., et al.
Publicado: (2023) -
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
por: Lee, Hyun A, et al.
Publicado: (2022) -
PB2059: SENSITIVITY AND SUBGROUP ANALYSES FURTHER SUPPORT CLINICAL SIMILARITY IN EFFICACY BETWEEN ABP 959 AND ECULIZUMAB REFERENCE PRODUCT IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
por: Kulasekararaj, Austin, et al.
Publicado: (2023)