NCT06310824

Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®

A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® Sourced From the European Union and United States in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Xentria, Inc. · Industry
• Sex: Male
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®

Detailed description

This study is a Phase 1, double-blind, randomized, single dose, parallel-group, 3-arm, Pharmacokinetic (PK) study designed to assess the biosimilarity, including the PK, Pharmacodynamics (PD), safety, tolerability, and immunogenicity of MAB-22 compared with reference Prolia® sourced from the European Union (EU) and United States (US) after single subcutaneous (SC) injection in healthy male participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	MAB-22	60mg dose of a single subcutaneous injection
DRUG	EU-Prolia®	60mg dose of a single subcutaneous injection
DRUG	US-Prolia®	60mg dose of a single subcutaneous injection

Timeline

• Start date: 2024-06-05
• Primary completion: 2025-07-22
• Completion: 2025-07-22
• First posted: 2024-03-15
• Last updated: 2025-07-29

Locations

2 sites across 2 countries: Hungary, Netherlands

Regulatory

• FDA-regulated drug study