AVT03 With Prolia in Healthy Male Subjects

Phase 1 Completed 209 enrolled Alvotech Swiss AG

RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start: 2022-06-29
Primary completion: 2023-10-16
Completion: 2023-10-16

Publications

Pretorius A, Bullo F, Jaskiewicz L, Stamatakos S, Otto H, Rai M, Ruffieux R, Sattar A, Leutz S, Berti F. A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, pharmacodynamic, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (60 mg/mL) in healthy male adults. Expert Opin Investig Drugs. 2025 Jun;34(6):527-537. doi: 10.1080/13543784.2025.2505466. Epub 2025 May 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AVT03	Unknown	60 mg	Subcutaneous
Comparator	Denosumab	Monoclonal antibody	60 mg	Subcutaneous

Indications

No indication recorded.