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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02931214 | Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers | PHASE1 | COMPLETED | 58 | — | — | Aug 1, 2016 | Nov 1, 2018 | Mar 4, 2019 | 1 | United States |
Treatment related adverse events as a measure of safety and tolerability of GMI-1359
| Arm | Type | Description |
|---|---|---|
| GMI-1359 | EXPERIMENTAL | Dose escalation |
| Placebo | EXPERIMENTAL | Dose escalation |
| Name | Type | Description |
|---|---|---|
| GMI-1359 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Healthy adult male or females, 19-60 years of age (inclusive). 2. Medically healthy with no clinically significant screening results. 3. Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth...