MB09, a denosumab biosimilar candidate: Biosimilarity demonstration in a phase I study in healthy subjects.

ABSTRACT: This was a Phase I, randomized, double-blinded, three-arm, single-dose, parallel study aimed to demonstrate pharmacokinetic (PK) similarity between MB09 (a denosumab biosimilar candidate) and reference denosumab (XGEVA® from European Union [EU-reference] and United States [US-reference]) in a healthy male population. The primary PK endpoints included: Area under the serum concentration versus time curve from time 0 to the last quantifiable concentration timepoint (AUC_0-last); and maximum observed serum concentration (C_max). Secondary endpoints included: AUC from time 0 extrapolated to infinity (AUC_0-∞), time to reach maximum observed concentration, clearance, terminal phase half-life, pharmacodynamic, safety, and immunogenicity assessments. A total of 255 s

SUBMITTER: Tomaszewska-Kiecana M 

PROVIDER: S-EPMC11359093 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature