Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as bococizumab (PF-04950615), Bococizumab
RN316 · 9 trials · 4 indications
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.
Maximum observed concentration.
| Arm | Type | Description |
|---|---|---|
| Bococizumab 150mg | EXPERIMENTAL | Bococizumab 150mg autoinjector (pre-filled pen) |
| Bococizumab 75mg | EXPERIMENTAL | Bococizumab 75mg autoinjector (pre-filled pen) |
| Bococizumab 150mg placebo | PLACEBO_COMPARATOR | Bococizumab 150mg placebo autoinjector (pre-filled pen) |
| Bococizumab 75mg placebo | PLACEBO_COMPARATOR | Bococizumab 75mg autoinjector (pre-filled pen) |
| Bococizumab (PF-04950615; RN316) | EXPERIMENTAL | Bococizumab (PF-04950615; RN316) |
| placebo | PLACEBO_COMPARATOR | - |
| Bococizumab (PF-04950615;RN316) | EXPERIMENTAL | Bococizumab (PF-04950615;RN316) |
| Atorvastatin | ACTIVE_COMPARATOR | - |
| Population A | EXPERIMENTAL | A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups. |
| Population B | EXPERIMENTAL | A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups. |
| Single 150 mg PF-04950615 dose administered to the abdomen | ACTIVE_COMPARATOR | - |
| Single 150 mg PF-04950615 dose administered to the upper arm | EXPERIMENTAL | - |
| Single 150 mg PF-04950615 dose administered to the thigh | EXPERIMENTAL | - |
| RN316 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bococizumab 150mg | BIOLOGICAL | Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection. |
| Bococizumab 75mg | BIOLOGICAL | Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection. |
| Bococizumab 150mg placebo | BIOLOGICAL | Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection. |
| Bococizumab 75mg placebo | BIOLOGICAL | Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection. |
| Bococizumab (PF-04950615; RN316) | DRUG | 150 mg every 2 weeks, subcutaneous injection for 52 weeks. |
| Placebo | OTHER | Subcutaneous injection every 2 weeks for 52 weeks. |
| Bococizumab (PF-04950615;RN316) | DRUG | 150 mg every 2 weeks by subcutaneous injection for 24 weeks |
| Atorvastatin | DRUG | Atorvastatin PO QD |
| Placebo for Bococizumab (PF-04950615;RN316) | OTHER | 150 mg every 2 weeks by subcutaneous injection for 24 weeks |
| Placebo for atorvastatin | OTHER | PO QD |
| Ezetimibe | DRUG | Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open) |
| 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: * Treated with a statin - Fasting LDL-C \>=70mg/dL and triglycerides \<=400mg/dL Exclusion Criteria: * Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled...
RN316 is an investigational monoclonal antibody developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 clinical trial in healthy adult volunteers. Its therapeutic indications have not been disclosed, and it remains in early clinical development rather than being an approved medicine.
RN316 is made by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 study of RN316 conducted in the United States. The drug is an investigational monoclonal antibody and is not a marketed product.
RN316 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. Because only Phase 1 testing has been completed, RN316 is investigational and has not been approved by the FDA for any use.
RN316 has been evaluated in one completed Phase 1 trial, NCT00991159, titled a study to assess the safety and tolerability of RN316 (PF-04950615) when administered to healthy adult subjects. The trial enrolled 48 healthy volunteers in the United States and used a randomized, double-blind design.
Yes, RN316 is also known as PF-04950615. The two names refer to the same Pfizer monoclonal antibody. The completed Phase 1 trial, NCT00991159, lists the drug under both designations, so searches for either name point to the same investigational asset.
RN316 is an investigational monoclonal antibody being developed by Pfizer, Inc. Its intended therapeutic indications have not been disclosed. The only completed study, NCT00991159, was a Phase 1 safety and tolerability trial in 48 healthy adult volunteers rather than in patients with a specific disease.