Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06732804 | Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio | PHASE1 | COMPLETED | 385 | — | — | Feb 11, 2025 | Jan 8, 2026 | Jan 20, 2026 | 3 | Australia, New Zealand |
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...