Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVT80 · 1 trial · 1 indication
PK endpoint of Cmax.
| Arm | Type | Description |
|---|---|---|
| AVT80 | EXPERIMENTAL | Single subcutaneous administration of AVT80 |
| Geographical region 1 Entyvio | ACTIVE_COMPARATOR | Single subcutaneous administration of Geographical region 1 Entyvio |
| Geographical region 2 Entyvio | ACTIVE_COMPARATOR | Single subcutaneous administration of Geographical region 2 Entyvio |
| Name | Type | Description |
|---|---|---|
| AVT80 | BIOLOGICAL | Single subcutaneous injection of AVT80 (108mg) |
| Geographical region 1 Entyvio | BIOLOGICAL | Single subcutaneous injection of Geographical region 1 Entyvio (108mg) |
| Geographical region 2 Entyvio | BIOLOGICAL | Single subcutaneous injection of Geographical region 2 Entyvio (108mg) |
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...
AVT80 is an investigational monoclonal antibody being studied in healthy male and female subjects. It is being evaluated for its comparative pharmacokinetics, safety, immunogenicity, and tolerability against Entyvio. The drug is currently in Phase 1 clinical development and is not approved for any indication.
AVT80 is being developed by Alvotech, a biopharmaceutical company traded on the NASDAQ under the ticker ALVO. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy volunteers.
AVT80 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation.
AVT80 has one completed Phase 1 clinical trial registered as NCT06732804. The study investigated comparative pharmacokinetics, safety, immunogenicity, and tolerability between AVT80 and Entyvio in 385 healthy male and female subjects across Australia and New Zealand.
AVT80 is not the same as Entyvio. AVT80 is an investigational monoclonal antibody being compared with Entyvio in a clinical trial. The study is designed to evaluate how AVT80 compares to Entyvio in terms of pharmacokinetics, safety, immunogenicity, and tolerability in healthy subjects.