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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06400719 | Pilot Study of AVT16 in Healthy Adult Subjects | PHASE1 | COMPLETED | 18 | — | — | May 29, 2024 | Nov 6, 2024 | Mar 11, 2025 | 1 | New Zealand |
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 ...