NCT05126784

AVT03 With Prolia in Healthy Male Subjects

A Randomized, Double-blind, Single-dose, Parallel-group Design, 2 Arm Study Comparing the Pharmacokinetic, Pharmacodynamic, Safety, Tolerability, and Immunogenicity Profiles of AVT03 and Prolia® in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: Male
• Age: 28 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
BIOLOGICAL	AVT03	AVT03 (biosimilar to denosumab) will be given as single subcutaneous injection
BIOLOGICAL	Prolia	Prolia (denosumab) will be given as single subcutaneous injection

Timeline

• Start date: 2022-06-29
• Primary completion: 2023-10-16
• Completion: 2023-10-16
• First posted: 2021-11-19
• Last updated: 2024-05-29

Locations

4 sites across 3 countries: Australia, New Zealand, South Africa