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Clinical Trial Summary

This study has been designed as a randomized, double-blind, single-dose, parallel-group study in healthy adult male subjects 28 years to 55 years old. The study will assess the PK, PD, safety, tolerability and immunogenicity of AVT03 compared to Prolia when administered as a single SC dose.


Clinical Trial Description

The study will consist of a 4 week screening period, a 252 day (36 weeks) treatment and assessment period, and an End of Study (EOS) visit on week 36 on Day 252. Subjects will undertake a screening visit between Day -28 and Day -1 to determine their eligibility for the study. On Day 1, eligible subjects will be randomized and will receive a single dose of AVT03 or Prolia as subcutaneous injection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05126784
Study type Interventional
Source Alvotech Swiss AG
Contact
Status Completed
Phase Phase 1
Start date June 29, 2022
Completion date October 16, 2023

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