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

NCT05299073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2025-01-03

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • mAbxience Research S.L.

    lead INDUSTRY

Principal Investigators

  • Monika Tomaszewska-Kiecana, MD · Biokinetica S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
28 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-03-18
Completion
2023-03-18
FDA Drug
Yes

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299073 on ClinicalTrials.gov