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Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

NCT05245669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2025-12-23

Study results available
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Summary

This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male volunteers.

Conditions

  • Healthy Male Subjects

Interventions

BIOLOGICAL

ENZ215

healthy volunteers receive ENZ215 (60mg) once

BIOLOGICAL

EU Sourced Prolia

healthy volunteers receive Denosumab (60mg) once

BIOLOGICAL

US Sourced Prolia

healthy volunteers receive Denosumab (60mg) once

Sponsors & Collaborators

  • Alkem Laboratories Ltd

    collaborator INDUSTRY

  • Enzene Biosciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Nadine Abdullah · Celerion GB Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2024-05-22
Completion
2024-05-22

Countries

  • Bulgaria
  • 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 NCT05245669 on ClinicalTrials.gov