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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02918929 | A Study of EDP 305 in Healthy Subjects and Subjects With Presumptive NAFLD | PHASE1 | COMPLETED | 146 | — | — | Sep 1, 2016 | Jun 1, 2017 | Aug 21, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| EDP 305 SAD Cohorts | EXPERIMENTAL | EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration |
| EDP 305 MAD Cohorts | EXPERIMENTAL | EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral suspension, once daily for 14 days |
| EDP 305 SAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral suspension, once daily in one single administration |
| EDP 305 MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral suspension, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| EDP 305 | DRUG | - |
| Placebo | DRUG | placebo to match EDP 305 |
Inclusion Criteria for all SAD and MAD Subjects:: * An informed consent document signed and dated by the subject. * Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. * Female subjects must be of non-childbearing potential. * All male participants ...