CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 257 enrolled
Drug / intervention
MB09 +2 moredrug
Likely dose
MB09 35mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05299073
NCT05299073Phase 1Completed
CompareCT.gov

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

mAbxience Research S.L.·interventional·Posted Mar 28, 2022·Updated Jan 3, 2025

In Brief

A Phase 1 clinical trial evaluating MB09, US-sourced Xgeva, and 1 other intervention for Healthy Volunteers. Completed, enrolled 257 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesPoland
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedMar 28, 2022
Enrollment StartMar 1, 2022
Primary CompletionMar 18, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.3 years ago

Interventions

MB09drug

Single dose of 35mg SC administered

US-sourced Xgevadrug

Single dose of 35mg SC administered

EU-sourced Xgevadrug

Single dose of 35mg SC administered