Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed by Alvotech. It is currently in Phase 1 clinical development, studied in healthy adult subjects. The drug is not approved and remains in clinical trials.
AVT16 is being studied for use in healthy adult subjects as part of an early-stage clinical trial. The specific therapeutic indication has not been established, as the drug is in Phase 1 development.
AVT16 is being developed by Alvotech, a biopharmaceutical company. Alvotech is publicly traded under the ticker symbol ALVO.
AVT16 is in Phase 1 clinical development. A pilot study of the drug in healthy adult subjects has been completed, but the drug remains investigational and is not yet approved.
AVT16 has one completed Phase 1 clinical trial, identified as NCT06400719, titled "Pilot Study of AVT16 in Healthy Adult Subjects." The trial enrolled 18 participants in New Zealand and was not randomized or blinded.