A Randomised, Double-blind, Three-arm, Single-dose, Parallel Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of MB09 (Denosumab Biosimilar) and EU/US-sourced Xgeva® in Healthy Male Volunteers
The clinical trial evaluated the pharmacokinetic (PK) similarity, pharmacodynamics (PD), safety, and immunogenicity of MB09, a biosimilar to Xgeva, in healthy male volunteers. The study was conducted by mAbxience Research S.L. and involved 257 participants across three arms: MB09, US-sourced Xgeva, and EU-sourced Xgeva.
Indication: Healthy Volunteers
Modality: monoclonal antibody
Target: Denosumab Biosimilar (MB09)
Sponsor: mAbxience Research S.L.
Source URL: ClinicalTrials.gov
Source updated: Jan 03, 2025
Ingested: May 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Denosumab Biosimilar (MB09)
View original source fields
Condition raw: Healthy Volunteers
Condition normalized: Healthy Volunteers
Modality raw: Healthy Volunteers
Modality normalized: monoclonal antibody
Target raw: Denosumab Biosimilar (MB09)
Target normalized: Denosumab Biosimilar (MB09)