Approval Probability
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PF-06293620 · 1 trial · 1 indication
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.
Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.
ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer \>=1.88 was considered positive.
| Arm | Type | Description |
|---|---|---|
| Cohort 1-PF-06293620 or placebo | EXPERIMENTAL | Single Ascending Dose PF-06293620 or placebo |
| Cohort 2-PF-06293620 or placebo | EXPERIMENTAL | Single Ascending Dose PF-06293620 or placebo |
| Cohort 3-PF-06293620 or placebo | EXPERIMENTAL | Single Ascending Dose PF-06293620 or placebo |
| Cohort 4-PF-06293620 or placebo | EXPERIMENTAL | Single Ascending Dose PF-06293620 or placebo |
| Cohort 5-PF-06293620 or placebo | EXPERIMENTAL | Single Ascending Dose PF-06293620 or placebo |
| Cohort 6-PF-06293620 or placebo | EXPERIMENTAL | Multiple Ascending Dose PF-06293620 or placebo |
| Cohort 7 PF-06293620 or placebo | EXPERIMENTAL | Multiple Ascending Dose PF-06293620 or placebo |
| Cohort 8-PF-06293620 or placebo | EXPERIMENTAL | Multiple Ascending Dose PF-06293620 or placebo |
| Cohort 9-PF-06293620 or placebo | EXPERIMENTAL | Multiple Ascending Dose PF-06293620 or placebo |
| Name | Type | Description |
|---|---|---|
| PF-06293620 | BIOLOGICAL | subcutaneous, single dose 0.3 mg/kg |
| Placebo | BIOLOGICAL | Subcutaneous normal saline single dose |
Inclusion Criteria: * Men and women of non-childbearing potential with Type 2 Diabetes Mellitus * Subjects on stable doses of metformin \>/= 1500 mg daily (SAD cohorts) or \>/= 1000 mg daily (MAD cohorts) x 30 days prior to screening * HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at...
PF-06293620 is an investigational monoclonal antibody being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
PF-06293620 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug in patients with Type 2 Diabetes Mellitus.
PF-06293620 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational, meaning it has not yet received regulatory approval for any use.
PF-06293620 has one completed clinical trial, NCT02211261, a Phase 1 single and multiple dose study assessing safety, tolerability, and pharmacokinetics in subjects with Type 2 Diabetes Mellitus. The trial enrolled 84 participants in the United States.
PF-06293620 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, and its safety and efficacy have not been established for the treatment of Type 2 Diabetes Mellitus.