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

NCT06310824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2025-07-29

No results posted yet for this study

Summary

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

Conditions

  • Healthy Participants

Interventions

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

Sponsors & Collaborators

  • Xentria, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2025-07-22
Completion
2025-07-22
FDA Drug
Yes

Countries

  • Hungary
  • Netherlands

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 NCT06310824 on ClinicalTrials.gov