NCT06504966

Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®

A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Sourced From the European Union in Postmenopausal Women With Osteoporosis

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Xentria, Inc. · Industry
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®

Detailed description

A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Sourced from the European Union in Postmenopausal Women with Osteoporosis

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	MAB-22	Single subcutaneous dose of 60 mg
DRUG	Prolia®	Single subcutaneous dose of 60 mg

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2024-07-17
• Last updated: 2025-05-11

Regulatory

• FDA-regulated drug study