AVT03 With Prolia in Healthy Male Subjects

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

Outcome

Met primary endpoint

paper The 90% CI for the ratio of geometric means for primary PK parameters was contained between the pre-specified margins of 80.00% and 125.00% PMID 40357744 ↗

release “The PK study (AVT03-GL-P01), which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints.” alvotech.com ↗

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.