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AVT16 · 1 trial · 1 indication
Safety and Tolerability of AVT16
| Arm | Type | Description |
|---|---|---|
| AVT16 | EXPERIMENTAL | Single intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab |
| Name | Type | Description |
|---|---|---|
| AVT16 | BIOLOGICAL | Single intravenous administration of 300mg of AVT16 |
Inclusion Criteria: * Healthy male and female subjects aged between 18 and 55 years old inclusive * Medical history without evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety * Haematology and biochemistry tests within normal range Exclusion ...
AVT16 is an investigational monoclonal antibody developed by Alvotech. It has been studied in a Phase 1 pilot trial in healthy adult subjects. The clinical program is at an early stage, and the specific medical conditions AVT16 may eventually treat have not been disclosed.
AVT16 targets integrin alpha-4 beta-7, a protein involved in immune cell trafficking. By binding this integrin, the antibody is designed to interfere with inflammatory pathways associated with lymphocyte migration. This mechanism places AVT16 in the class of anti-integrin monoclonal antibodies.
AVT16 is being developed by Alvotech, a biotechnology company whose shares trade on the Nasdaq under the ticker ALVO. Alvotech is known for developing biosimilar and specialty antibody products. The company has advanced AVT16 into early clinical testing.
AVT16 is in Phase 1 clinical development. It has completed one Phase 1 pilot study in healthy adult volunteers. The program remains investigational, and AVT16 has not been approved by the FDA or any other regulatory agency for commercial use.
AVT16 has been evaluated in a single Phase 1 trial, NCT06400719, titled Pilot Study of AVT16 in Healthy Adult Subjects. The trial enrolled 18 healthy volunteers in New Zealand and is now completed. It was an uncontrolled study without randomization or blinding.