NCT05632211

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

A First-in-human, Randomized, Parallel Group, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, and Tolerability Between Subcutaneous AVT05, US-licensed Simponi®, and EU-approved Simponi® in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
BIOLOGICAL	AVT05	Pre filled syringes filled with AVT05
BIOLOGICAL	Simponi	Pre filled syringes filled with Simponi

Timeline

• Start date: 2022-12-16
• Primary completion: 2023-10-03
• Completion: 2023-10-03
• First posted: 2022-11-30
• Last updated: 2025-05-28
• Results posted: 2025-05-28

Locations

2 sites across 2 countries: New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study