Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01893528 | Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers | PHASE1 | COMPLETED | 49 | — | — | Jun 1, 2013 | Sep 1, 2014 | Nov 10, 2014 | 2 | United States |
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...