A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva
Status:
Recruiting
Trial end date:
2023-01-23
Target enrollment:
Participant gender:
Summary
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare
the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male
subjects.
During the course of the study, the similarity in pharmacokinetics will be assessed by
sampling the levels of drug in the blood, and by comparing these levels among the different
administration arms. Pharmacodynamics, safety, tolerability, and immunologic response to the
administered drugs will also be evaluated throughout.