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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02127801 | Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants | PHASE1 | COMPLETED | 74 | — | — | Oct 31, 2014 | Dec 31, 2015 | Dec 16, 2020 | 5 | Netherlands, New Zealand +2 |
| NCT01922661 | Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects | PHASE1 | COMPLETED | 24 | — | — | Aug 1, 2013 | May 1, 2014 | Jun 10, 2014 | 2 | United States |
The primary endpoint is the change in allergic symptom scale score at day 8
The primary endpoint is to assess treatment-emergent adverse events (TEAEs) from day 1 through day 113 (end of study).
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Participants in group A will receive REGN1908-1909 |
| Group B | EXPERIMENTAL | Participants in group B will receive placebo |
| Cohort 1 | EXPERIMENTAL | Dose 1 of REGN1908-1909 or placebo |
| Cohort 2 | EXPERIMENTAL | Dose 2 of REGN1908-1909 or placebo |
| Cohort 3 | EXPERIMENTAL | Dose 3 of REGN1908-1909 or placebo |
| Name | Type | Description |
|---|---|---|
| REGN1908-1909 | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: 1. Healthy men and women between the ages of 18 and 55 2. Positive allergen skin prick test 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide signed informed consent Exclusion Criteria: 1. Persistent, chronic, or active recurring infectio...