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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05108259 | To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects | PHASE1 | RECRUITING | 324 | — | — | Mar 30, 2022 | May 1, 2026 | May 31, 2025 | 1 | Spain |
Primary endpoints were equivalence of PK between PBP1502 and reference drugs in terms of AUC0-inf. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Primary endpoints were equivalence of PK between PBP1502 and reference drugs in terms of AUC0-last. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Primary endpoints were equivalence of PK between PBP1502 and reference drugs in terms of Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
| Arm | Type | Description |
|---|---|---|
| PBP1502 | EXPERIMENTAL | Adalimumab single dose 40 mg (100 mg/mL) by SC injection via pre-filled syringe (PFS) |
| EU-licensed Humira | ACTIVE_COMPARATOR | Adalimumab single dose 40 mg (100 mg/mL) by SC injection via PFS |
| US-licensed Humira | ACTIVE_COMPARATOR | Adalimumab single dose 40 mg (100 mg/mL) by SC injection via PFS |
| Name | Type | Description |
|---|---|---|
| PBP1502 | DRUG | 40 mg/0.4 mL single SC injection via PFS |
| EU-licensed Humira | DRUG | 40 mg/0.4 mL single SC injection via PFS |
| US-licensed Humira | DRUG | 40 mg/0.4 mL single SC injection via PFS |
Inclusion Criteria: 1. Healthy male or female subjects, between the age of 18 and 55 years, both inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead EC...