TrialSignal
Clinical trial intelligence report
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
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 20, 2026
NCT ID
NCT05299073
Status
COMPLETED
Phase
PHASE 1
Sponsor
mAbxience Research S.L.
Executive brief
Investment-Ready Snapshot
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.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT05299073
Indication
Healthy Volunteers
Modality
monoclonal antibody
Target
Denosumab Biosimilar (MB09)
Intervention
MB09, US-sourced Xgeva, EU-sourced Xgeva
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.