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 developed by Regeneron Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. No therapeutic indication for REGN2009 has been disclosed, and it remains in early clinical development rather than being an approved medicine.
REGN2009 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron sponsored the Phase 1 study of the compound conducted in the United States. The company has not publicly disclosed a therapeutic indication for this asset.
REGN2009 is in Phase 1 development. Its only recorded clinical trial was a Phase 1 study that has been completed. Because no later-stage trials have been registered, REGN2009 is investigational and has not been approved by the FDA for any use.
REGN2009 has been evaluated in one registered clinical trial, NCT01893528, titled a Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers. That Phase 1 trial enrolled 49 participants in the United States and is now completed.
The REGN2009 Phase 1 trial, NCT01893528, was a randomized, double-blind, controlled study of ascending single doses in healthy adult volunteers aged 18 years and older. It enrolled 49 participants across sites in the United States and evaluated safety and tolerability. The study is completed.