New biosimilar AVT80 compared to entyvio in healthy adults

NCT ID NCT06732804

Completed Knowledge-focused Sponsor: Alvotech Swiss AG Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 study tested a new biosimilar called AVT80 against the approved drug Entyvio in 385 healthy adults aged 18 to 55. The goal was to see how similarly the body processes each drug, and to check safety and immune reactions. Participants received a single injection of either AVT80 or one of two versions of Entyvio, and researchers compared drug levels and side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: AVT80 (a proposed biosimilar to Entyvio)
What this could lead to: If successful, this could support AVT80 as a more affordable alternative to Entyvio for treating inflammatory bowel disease.
What could go wrong: This is an early Phase 1 study in healthy people, not patients. It only checks how the drug moves through the body and safety, not whether it works for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEALTHY MALE AND FEMALE SUBJECTS

Contacts and locations

Locations

Investigational Site 0002

Auckland, New Zealand
NZCR

Christchurch, 8011, New Zealand
Veritus Research Pty Ltd

Bayswater, Australia

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