NCT05245669

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

A Randomized, Double-blind, Three-arm, Parallel-group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (ENZ215, EU-sourced Prolia®, and US-sourced Prolia®) in Healthy Adult Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Enzene Biosciences Ltd. · Industry
• Sex: Male
• Age: 28 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Approximately 207 subjects will be enrolled into 3 groups (69 in each group) in parallel. The subjects may be enrolled in multiple groups at the site. All eligible subjects will be assigned to one of the three treatment groups in 1:1:1 ratio i.e. ENZ215 or US-sourced Prolia® or EU-sourced Prolia® to enter into the study period of 39 weeks. The study duration will be approximately 16 months (i.e. 6 months of recruitment period, 4 weeks of screening period and approximately 39 weeks (270 days) of study period). Each subject will be required to visit the site for a total of 20 visits: visit 1 - screening visit, visit 2 - day 0 to day 2, visit 3 - day 3, visit 4 - day 4, visit 5 - day 5, visit 6 - day 6, visit 7 - day 8, visit 8 - day 10, visit 9 - day 12, visit 10 - day 16, visit 11 - day 21, visit 12 - day 28 (week 4), visit 13 - day 42 (week 6), visit 14 - day 63 (week 9), visit 15 - day 90 (week 13), visit 16 - day 119 (week 17), visit 17 - day 147 (week 21), visit 18 - day 180 (week 26), visit 19 day - 224 (week 32), and visit 20 - day 270 (week 39). A window period of ±1 day is allowed for visit 12 (day 28), window period of ±3 days are allowed from day 42 (week 6) to day 180 (week 26), A window period of ±5 days are allowed from day 224 (week 32) to day 270 (week 39). End of Study Assessment will be performed on day 270 (week 39) or at the time of early discontinuation of the subject.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-10
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2022-02-18
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

2 sites across 2 countries: Bulgaria, Poland