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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02168595 | Placebo-controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1271 in Healthy Volunteers | PHASE1 | COMPLETED | 28 | — | — | Jun 1, 2014 | Apr 1, 2015 | Feb 27, 2018 | 1 | United States |
Treatment related adverse events as a measure of safety and tolerability of GMI-1271 (time frame: Day 1-15)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 2 mg/kg GMI-1271 or matching placebo |
| Cohort 2 | EXPERIMENTAL | 5 mg/kg GMI-1271 or matching placebo |
| Cohort 3 | EXPERIMENTAL | 10 mg/kg GMI-1271 or matching placebo |
| Name | Type | Description |
|---|---|---|
| GMI-1271 | DRUG | GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Healthy adult male and/or females, 19 to 60 years of age, inclusive. 2. Medically healthy with no clinically significant screening results (e.g., laboratory profiles, medical histories, vital signs, ECGs, physical examination) as deemed by the PI. 3. Females of childbearing p...