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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04744363 | Pharmacokinetics, Safety and Tolerability Study of AVT04 to EU Approved and US Licensed Stelara (Ustekinumab) | PHASE1 | COMPLETED | 294 | — | — | May 25, 2021 | Mar 19, 2022 | May 23, 2022 | 4 | Australia, New Zealand |
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT04, US Stelara EU Stelara
Venous blood samples will be collected for measurement of serum concentration of AVT04, EU Stelara, US Stelara
| Arm | Type | Description |
|---|---|---|
| AVT04 45 mg SC | EXPERIMENTAL | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| US Stelara 45 mg SC | ACTIVE_COMPARATOR | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| EU Stelara 45 mg SC | ACTIVE_COMPARATOR | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| Name | Type | Description |
|---|---|---|
| Stelara PFS | DRUG | Pre filled syringes filled with AVT04 and Stelara |
Inclusion Criteria: Subjects are eligible to be included in the study only if all of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration: 1. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the ...