Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Single dose-group A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 0.03 mg/kg or placebo iv | OTHER | - |
| 0.1 mg/kg or placebo iv | OTHER | - |
| 0.3 mg/kg or placebo iv | OTHER | - |
| 1.0 mg/kg or placebo iv | EXPERIMENTAL | - |
| 3.0 mg/kg or placebo sc | OTHER | - |
| 10 mg/kg or placebo iv | OTHER | - |
| 0.3 mg/kg or placebo sc | OTHER | - |
| 0.1 mg/kg or placebo iv (multiple dose) | OTHER | - |
| 0.3 mg/kg or placebo iv (multiple dose) | OTHER | - |
| 3.0 mg/kg or placebo iv | OTHER | - |
| 0.1 mg/kg or placebo sc | OTHER | - |
| 0.3 mg/kg or placebo sc (multiple dose) | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Single dose-group A | BIOLOGICAL | PF-00547659, single iv dose |
| Multiple dose- Group B | BIOLOGICAL | PF-00547659, multiple dose |
| Multiple dose-Group B | BIOLOGICAL | PF-00547659, multiple dose |
Inclusion Criteria: * A positive histological diagnosis of UC ≥3 months prior to entry into the study. If a histological diagnosis is not available but all signs and symptoms suggest UC, the subject's eligibility should be discussed with Pfizer. * Active UC as defined by a score of ≥6 on the Mayo s...
PF-00547659 is an investigational monoclonal antibody being studied for the treatment of active ulcerative colitis, a form of inflammatory bowel disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
PF-00547659 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is in Phase 1 clinical trials for ulcerative colitis.
PF-00547659 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 1 study of the drug in patients with active ulcerative colitis has been completed.
PF-00547659 has one completed Phase 1 clinical trial, identified as NCT00928681, which investigated the safety and efficacy of the drug in 80 patients with active ulcerative colitis. The study was conducted in multiple European countries, including Belgium, Czechia, Denmark, Germany, Norway, Slovakia, and Spain.
PF-00547659 is the drug name used in clinical trials. No alternative names have been established for this investigational monoclonal antibody, which is being studied for ulcerative colitis.