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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04406415 | Oral Nafamostat in Healthy Volunteers (NAF-101) | PHASE1 | COMPLETED | 17 | — | — | Sep 21, 2020 | May 14, 2021 | Sep 24, 2024 | 1 | United States |
Number of participants with adverse events including out-of-range clinical laboratory measures, vital signs, ECG, and spontaneous adverse event reports throughout the 14 day study period
| Arm | Type | Description |
|---|---|---|
| 10 mg | EXPERIMENTAL | 10 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| 50 mg | EXPERIMENTAL | 50 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| 100 mg | EXPERIMENTAL | 100 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| 200 mg | EXPERIMENTAL | 200 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| Placebo | PLACEBO_COMPARATOR | Placebo administered three times a day (t.i.d., approximately q8h) for up to 5 days |
| Name | Type | Description |
|---|---|---|
| Nafamostat Mesilate | DRUG | Oral nafamostat, 10, 50, 100, or 200 mg administered three times daily for up to 5 days |
| Placebo | DRUG | Oral placebo administered three times daily for up to 5 days |
Inclusion Criteria: 1. Males or females, age 18 to 70 years old, able and willing to provide written informed consent to participate in the study; 2. Subjects must be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead el...