Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-05335810 Dose A · 1 trial · 1 indication
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Cohort 5 | EXPERIMENTAL | - |
| Cohort 6 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-05335810 Dose A | BIOLOGICAL | Single SC Injection |
| PF-05335810 Dose B | BIOLOGICAL | Single Subcutaneous Injection(s) |
| Placebo | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-04950615 Dose A | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-05335810 Dose C | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-04950615 | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-05335810 Dose D | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-05335810 Dose E | BIOLOGICAL | Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months. |
Inclusion Criteria: * On stable daily doses of a statin for 45 days prior to receiving study treatment. * Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization. Exclusion Criteria: * History of a cardiovascular or cerebrovascular event or ...
PF-05335810 Dose A is an investigational monoclonal antibody being developed by Pfizer, Inc. (NYSE: PFE) for metabolic conditions. It is in Phase 1 clinical development for hypercholesterolemia, with studies also conducted in healthy volunteers and adults with Type 1 diabetes.
PF-05335810 Dose A is being studied for use in hypercholesterolemia, a condition of high cholesterol. Clinical trials have also assessed its safety in healthy volunteers and in adults with Type 1 diabetes, though the primary focus is on hypercholesterolemia.
PF-05335810 Dose A is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.
PF-05335810 Dose A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are completed, and the drug remains under study for metabolic indications.
PF-05335810 Dose A was studied in a completed Phase 1 trial (NCT01720537) assessing safety in hypercholesterolemic subjects, with 133 participants in the United States. Additional completed trials (NCT01740609, NCT02038764) evaluated related compounds in healthy volunteers and Type 1 diabetes patients.