Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN2009 · 1 trial · 1 indication
The primary endpoint in this study is the incidence and severity of Treatment Emergent Adverse Events (TEAEs) in healthy volunteers treated with REGN2009 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 15.
| Arm | Type | Description |
|---|---|---|
| REGN2009 dose level 1 | EXPERIMENTAL | Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo) |
| REGN2009 dose level 2 | EXPERIMENTAL | Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo) |
| REGN2009 dose level 3 | EXPERIMENTAL | Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo) |
| Name | Type | Description |
|---|---|---|
| REGN2009 | DRUG | - |
| placebo | OTHER | - |
Inclusion Criteria: 1. Healthy men and women ages 18 to 65 years inclusive 2. Body mass index between 18.0 kg/m\^2 and 30.0 kg/m\^2, inclusive Exclusion Criteria: 1. Pregnant or breast-feeding women 2. Any clinically significant abnormalities observed during screening (day -21 to day -2) 3. Known...
REGN2009 is an investigational small molecule being studied in healthy volunteers. It is being evaluated for safety and tolerability in a Phase 1 clinical trial. The drug is not approved for any condition and remains in clinical development.
REGN2009 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker REGN. The company is conducting clinical research on this investigational small molecule.
REGN2009 is in Phase 1 clinical development. A Phase 1 trial assessing the safety and tolerability of ascending single doses in healthy volunteers has been completed. The drug is investigational and has not been approved by regulatory authorities.
REGN2009 has one completed clinical trial, NCT01893528, titled "Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers." This Phase 1 study enrolled 49 participants in the United States and was randomized, double-blind, and controlled.
REGN2009 is the primary name for this investigational drug. No alternative names have been reported for this asset in clinical development.