At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 207 enrolled
Drug / intervention
ENZ215 +2 morebiological
Likely dose
ENZ215 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating ENZ215, EU Sourced Prolia, and 1 other intervention for Healthy Male Subjects. Completed, enrolled 207 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Male Subjects
CountriesBulgaria, Poland
CollaboratorsAlkem Laboratories Ltd
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartJan 2022
First PostedFeb 2022
Primary CompletionMay 2024
TodayJul 2026
First PostedFeb 18, 2022
Enrollment StartJan 10, 2022
Primary CompletionMay 22, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.4 years ago
Interventions
ENZ215biological
healthy volunteers receive ENZ215 (60mg) once
EU Sourced Proliabiological
healthy volunteers receive Denosumab (60mg) once
US Sourced Proliabiological
healthy volunteers receive Denosumab (60mg) once