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New biosimilar AVT80 compared to entyvio in healthy adults

NCT ID NCT06732804

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

385 people

The number who actually took part.

Started

Feb 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy male and female participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol. * Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 17.0 to 32.0 kg/m2 (inclusive). * Participant must be 18 to 55 years old inclusive, at the time of signing the ICF. Exclusion Criteria: * Participant has a history of relevant drug and/or food allergies. * Participant has a history of hypersensitivity to Entyvio, AVT80, or their constituents. * Participant has any past or concurrent medical conditions that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (e.g., demyelinating disorders).

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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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