AVT03 With Xgeva in Healthy Male Subjects

Summary

This study has been designed as a randomized, double-blind, parallel-group study and in healthy adult male subjects of age 28 years to 55 years old. The study will assess the PK, safety and tolerability of AVT03 compared to US-Xgeva when administered as a single 120 mg SC dose

Timeline

Start

2023-07-21

Primary completion

2024-04-15

Completion

2024-04-15

Outcome

Met primary endpoint

paper The 90% CIs for the ratio of geometric means for the primary PK parameters were entirely contained within the prespecified margins of 80.00% and 125.00% PMID 40357869 ↗

release “Two additional studies comparing the pharmacokinetics, safety, and tolerability of AVT03 to Prolia and Xgeva, respectively, have also met their primary endpoint” alvotech.com ↗

Publications

• Tomaszewska-Kiecana M, Bullo F, Jaskiewicz L, Stamatakos S, Otto H, Rai M, Sattar A, Leutz S, Berti F. A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (70 mg/mL) in healthy male adults. Expert Opin Investig Drugs. 2025 Jun;34(6):539-546. doi: 10.1080/13543784.2025.2505469. Epub 2025 May 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AVT03	Unknown	120 mg	Subcutaneous
Comparator	Denosumab	Monoclonal antibody	120 mg	Subcutaneous

Indications

No indication recorded.