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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01933763 | An Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of REGN1193 | PHASE1 | COMPLETED | 56 | — | — | Aug 1, 2013 | Jan 1, 2015 | Mar 13, 2015 | 1 | United States |
The primary endpoint in this study is the incidence and severity of TEAEs (treatment emergent adverse events) in healthy volunteers treated with REGN1193 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 16.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Participants in Group A will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo. |
| Group B | EXPERIMENTAL | Participants in Group B will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo. |
| Name | Type | Description |
|---|---|---|
| REGN1193 | DRUG | - |
| Placebo | OTHER | - |
Inclusion Criteria: 1. Healthy men and women 18 to 45 years of age (inclusive) 2. Body mass index 18.0 to 30.0 kg/m\^2 (inclusive) 3. Normal standard 12-lead ECG 4. Willing and able to comply with clinic visits and study-related procedures 5. Provide signed informed consent 6. For sexually active m...