NCT05245669View on ClinicalTrials.gov

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

PHASE1UnknownINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

February 7, 2022

Primary Completion Date

May 31, 2024

Study Completion Date

May 31, 2024

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

Trial Locations (2)

1000

RECRUITING

MC Comac Medical, Sofia

02-172

RECRUITING

MTZ Clinical Research powered by Pratia, Pratia S.A, Warsaw

Sponsors

Collaborators (1)

Alkem Laboratories Ltd
All Listed Sponsors
collaborator

Alkem Laboratories Ltd

INDUSTRY

lead

Enzene Biosciences Ltd.

INDUSTRY

NCT05245669 - Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers | Biotech Hunter | Biotech Hunter