Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PBO · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Q28d Dosing Arm | EXPERIMENTAL | A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month. |
| Q14d Dosing Arm | EXPERIMENTAL | A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks. |
| Name | Type | Description |
|---|---|---|
| PBO | DRUG | Placebo Q28d |
| 200mg PF-04950615 (RN316) | DRUG | PF-04950615 200 mg, Q28d |
| 300mg PF-04950615 (RN316) | DRUG | PF-04950615 300 mg, Q28d |
| PF-04950615 | DRUG | PF-04950615 50mg, Q14d |
Inclusion Criteria: * Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial. * Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and...
PBO is an investigational small molecule being developed for the treatment of hypercholesterolemia, a condition of high cholesterol levels in the blood. It is intended for use in patients who are also on a statin, as studied in clinical trials. The drug is currently in Phase 2 clinical development.
PBO is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with hypercholesterolemia.
PBO is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for its effects on cholesterol levels in patients with hypercholesterolemia.
PBO has one completed Phase 2 clinical trial registered under NCT01592240, titled 'Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin.' The trial enrolled 354 participants in the United States and was randomized, double-blind, and controlled.
Yes, PBO is also known as PF-04950615 and RN316. These names refer to the same investigational drug being developed by Pfizer for hypercholesterolemia. The clinical trial NCT01592240 uses the name PF-04950615 (RN316) to describe the drug being studied.