Approval Probability
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PF-04287881 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 (optional) | EXPERIMENTAL | If intermediate or repeat dose level is needed; dose will not exceed 1100 mg. |
| Cohort 5 (Japanese) | EXPERIMENTAL | - |
| Cohort 6 (Japanese) | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Cohort 5 | EXPERIMENTAL | - |
| Cohort 6 | EXPERIMENTAL | - |
| Cohort 7 | EXPERIMENTAL | - |
| Cohort 8 | EXPERIMENTAL | Japanese volunteers, low dose previously tested (based on PK) |
| Cohort 9 | EXPERIMENTAL | Japanese volunteers, intermediate dose previously tested (based on PK) |
| Cohort 10 | EXPERIMENTAL | Japanese volunteers, high dose previously tested (based on safety) |
| Name | Type | Description |
|---|---|---|
| PF-04287881 | DRUG | 500 mg once daily for 10 days |
| Placebo | DRUG | To match 500 mg dose once daily for 10 days |
Inclusion Criteria: * Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule. * Women of non-childbearing potential only. * Japanese subjects must have 4 Japanese grandparents who were born in Japan. Exclusion Criteria: * Previous antibiotic use wi...
PF-04287881 is an investigational small molecule being developed by Pfizer for the treatment of Respiratory Tract Infections. It is currently in Phase 1 clinical development, and it is not yet approved by the FDA. The drug is being studied in healthy adult volunteers to evaluate its safety and pharmacokinetics.
PF-04287881 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule intended for the treatment of Respiratory Tract Infections and is currently in Phase 1 clinical development.
PF-04287881 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, both involving healthy adult volunteers, to assess the safety, tolerability, and pharmacokinetics of the drug for Respiratory Tract Infections.
PF-04287881 has been studied in two completed Phase 1 clinical trials. The first, NCT00793000, enrolled 80 healthy adults in the United States to evaluate safety and pharmacokinetics. The second, NCT01026545, enrolled 39 healthy adults in the United States to assess multiple oral dose safety, tolerability, and pharmacokinetics.
PF-04287881 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Respiratory Tract Infections. The two completed trials were conducted in healthy volunteers to evaluate safety and pharmacokinetics, and the drug has not yet progressed to later-stage trials or regulatory approval.