A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants

Phase 1 Completed 336 enrolled Alvotech Swiss AG IQVIA Pty Ltd · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as a single 50 mg/0.5 mL SC dose.

Timeline

Start: 2022-12-16
Primary completion: 2023-10-03
Completion: 2023-10-03

Publications

Wynne C, Lorch U, Krantz E, Katial R, Ashdown T, Luque M, Sattar A, Rai M, Vashishta L, Petrovic K, Ruffieux R, Leutz S, Berti F. Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study. BioDrugs. 2026 Jan;40(1):121-133. doi: 10.1007/s40259-025-00749-7. Epub 2025 Nov 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AVT05	Monoclonal antibody	50 mg	Subcutaneous
Comparator	Golimumab	Monoclonal antibody	50 mg	Subcutaneous

Indications

No indication recorded.