A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva

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.

Timeline

Start

2022-03-01

Primary completion

2023-03-18

Completion

2023-03-18

Drugs

Indications

No indication recorded.