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RN316 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| RN316 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RN316 | BIOLOGICAL | Single, escalating doses of RN316 administered IV. Doses planned for testing = 0.3, 1.0, 3.0, 6.0, 12.0, and 18.0 mg/kg. |
Inclusion Criteria: * Healthy, ambulatory men and women (of non-childbearing potential) ages 18 -70 inclusive. * Baseline total cholesterol ≥ 200 mg/dl, baseline LDL ≥ 130 mg/dl. * BMI 18.5 to 35, and body weight ≤150 kg, inclusive. Exclusion Criteria: * Evidence of clinically significant disease...
RN316 is an investigational monoclonal antibody being developed by Pfizer, Inc. It was studied in a Phase 1 clinical trial to assess its safety and tolerability when administered to healthy adult subjects. The drug is not approved and remains in clinical development.
RN316 was studied in healthy volunteers as part of a Phase 1 trial. The trial was designed to assess the safety and tolerability of the drug when given to healthy adult subjects. No specific disease indication has been established for RN316.
RN316 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company sponsored a Phase 1 clinical trial of the drug in the United States.
RN316 is in Phase 1 clinical development. A Phase 1 trial of the drug has been completed, and the drug remains investigational. It has not been approved by regulatory authorities.
RN316 has one completed clinical trial, identified as NCT00991159. This Phase 1 study, titled "A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects," enrolled 48 participants in the United States.
Yes, RN316 is also known as PF-04950615. The clinical trial NCT00991159 refers to the drug as RN316 (PF-04950615), indicating that these names are used interchangeably for the same investigational monoclonal antibody.