Approval Probability
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Adjusted LOA
ML Risk
PBP1502 · 1 trial · 1 indication
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...
PBP1502 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a trial comparing its pharmacokinetics and safety to Humira in healthy subjects. The drug is not approved and remains under investigation.
PBP1502 is being developed by Prestige Consumer Healthcare Inc., a company traded under the ticker PBH. The company is conducting a Phase 1 trial of the drug in healthy volunteers.
PBP1502 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in a single active trial involving healthy volunteers.
PBP1502 is being studied in one Phase 1 trial, NCT05108259, which compares its pharmacokinetics and safety to Humira in healthy subjects. The trial is recruiting 324 participants in Spain and is randomized, double-blind, and active-controlled.
PBP1502 is not the same as Humira. It is a separate investigational drug being compared to Humira in a clinical trial to assess its pharmacokinetics and safety. The trial is active-controlled, meaning Humira serves as the comparator.