Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MGAWN1 · 1 trial · 1 indication
| 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...
MGAWN1 is an investigational small molecule being developed for West Nile Virus. It is currently in Phase 1 clinical development and has not been approved by the FDA. One Phase 1 trial has been completed to evaluate its safety in healthy adults.
MGAWN1 is being developed by MacroGenics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MGNX. The company is conducting clinical research to evaluate the safety of this investigational drug for West Nile Virus.
MGAWN1 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It is not FDA approved and is still undergoing clinical evaluation for safety in healthy volunteers.
MGAWN1 has one completed Phase 1 clinical trial, identified as NCT00515385. This trial, titled "A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults," enrolled 40 participants in the United States and was placebo-controlled and double-blind.
No, MGAWN1 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for West Nile Virus. The completed Phase 1 trial focused on safety in healthy adults, and the drug has not yet received regulatory approval.