NCT05299073

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: mAbxience Research S.L. · Industry
• Sex: Male
• Age: 28 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary PK parameter endpoints are AUC0-last and Cmax for denosumab. The secondary PK endpoints will include all other PK parameters for denosumab, including AUC0-∞, Tmax, CL and t1/2. For the primary PK Analysis, an analysis of variance (ANOVA) model with treatment and stratification factors as fixed effects will be performed on the natural log transformed values of Cmax, AUC0 last, and AUC0-∞. Estimates of geometric mean ratios together with the corresponding 90% confidence intervals (CI) will be derived for the comparisons of the PK parameters as follows: * MB09 versus EU-Xgeva® * MB09 versus US-Xgeva® * EU-Xgeva® versus US-Xgeva® Bioequivalence will be concluded if the 90% CIs for the test to reference ratios of the geometric least square means for AUC0-last and Cmax are entirely contained within the \[80%, 125%\] interval. For the PD Analysis, an analysis of covariance (ANCOVA) model with treatment and stratification factors as fixed effects and logged pre-dose sCTX concentrations fitted as a covariate will be performed on the natural log-transformed values of AUEC0 253 and AUIC0 253. Adverse events will be coded using MedDRA Version 24. All AE data will be presented in a data listing. Treatment-emergent AEs will be summarised by treatment and overall, as well as by severity and relationship to study drug. Serious AEs and AEs leading to discontinuation of study drug will also be presented in the data listings and summarised by treatment and overall. The incidence of ADA to denosumab and the neutralizing potential and titre of positive ADAs will be reported. All immunogenicity data will be presented in the data listings.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MB09	Single dose of 35mg SC administered
DRUG	US-sourced Xgeva	Single dose of 35mg SC administered
DRUG	EU-sourced Xgeva	Single dose of 35mg SC administered

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-03-18
• Completion: 2023-03-18
• First posted: 2022-03-28
• Last updated: 2025-01-03
• Results posted: 2025-01-03

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated drug study