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

Phase 1

Recruiting

• Conditions: Healthy Male Subjects
• Interventions: Biological: EU Sourced Prolia; Biological: ENZ215; Biological: US Sourced Prolia

• Registration Number: NCT05245669
• Lead Sponsor: Enzene Biosciences Ltd.

Brief 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

Not available

Study Timeline

• Study First Submitted: 2022-01-11
• Study Start: 2022-02-07
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-18
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EU Sourced Prolia	EU Sourced Prolia	EU sourced Prolia Injection:- 60 mg Denosumab (EU sourced Prolia) will be administered subcutaneously on day 1.
ENZ215	ENZ215	ENZ215 Injection:- 60 mg Denosumab (ENZ215) will be administered subcutaneously on day 1.
US Sourced Prolia	US Sourced Prolia	US sourced Prolia Injection:- 60 mg Denosumab (US sourced Prolia) will be administered subcutaneously on day 1.

Primary Outcome Measures

Name	Time	Method
Maximum observed drug concentration (Cmax) of ENZ215 and EU- and US-sourced Prolia®	270 days
Area under the drug concentration-time curve from day 0 to day 270 (AUC0-t) of ENZ215 and EU- and US-sourced Prolia®	270 days
Area under the drug concentration-time curve from time 0 to infinity (AUC0-inf) of ENZ215 and EU- and US-sourced Prolia®	270 days

Secondary Outcome Measures

Name	Time	Method
Partial area under the drug concentration-time curve from time 0 (pre-dose) to day 28	28 days
Apparent systemic clearance (CL/F)	270 days
Time to reach Cmax (tmax)	270 days
Area under the effect curve (AUEC) from time 0 to Day 270 for serum CTX-1 percent inhibition	270 days
Terminal elimination half-life (t1/2)	270 days

Trial Locations

Locations (2)

MC Comac Medical; 🇧🇬 Sofia, Sofia City Province, Bulgaria

MTZ Clinical Research powered by Pratia, Pratia S.A; 🇵🇱 Warszawa, Poland