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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00515385 | A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults | PHASE1 | COMPLETED | 40 | — | — | Aug 1, 2007 | Jan 1, 2009 | Feb 22, 2022 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1a | EXPERIMENTAL | Cohort 1 completed |
| 1b | PLACEBO_COMPARATOR | Cohort 1 placebo completed |
| 2a | EXPERIMENTAL | Cohort 2 completed completed |
| 2b | PLACEBO_COMPARATOR | Cohort 2 placebo completed |
| 3a | EXPERIMENTAL | Cohort 3 active |
| 3b | PLACEBO_COMPARATOR | Cohort 3 placebo |
| 4a | EXPERIMENTAL | Cohort 4 active |
| 4b | PLACEBO_COMPARATOR | Cohort 4 placebo |
| 5a | EXPERIMENTAL | Cohort 5 active |
| 5b | PLACEBO_COMPARATOR | Cohort 5 placebo |
| Name | Type | Description |
|---|---|---|
| MGAWN1 | DRUG | Eight subjects per cohort, each receives a single IV infusion of MGAWN1 of saline control on study day 0 (6 MGAWN1, 2 saline control. Cohort 1 - 0.3 mg/kg Cohort 2 - 1 mg/kg Cohort 3 - 3 mg/kg Cohort 4 - 10 mg/kg Cohort 5 - 30 mg/kg |
| Placebo | OTHER | Single IV dose |
Inclusion Criteria: 1. Written informed consent obtained from the subject including consent for the use of research-related health information, before performance of any study-related procedure including screening procedures 2. Healthy adult male or female subjects aged 18-65 years, with a body mas...