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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04559126 | A Study of EDP-297 in Healthy Subjects | PHASE1 | COMPLETED | 82 | — | — | Sep 8, 2020 | Jun 21, 2021 | Oct 29, 2021 | 1 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| EDP-297 SAD Cohorts | EXPERIMENTAL | EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration |
| EDP-297 MAD Cohorts | EXPERIMENTAL | EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days |
| EDP-297 SAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral solution, once daily in one single administration |
| EDP-297 MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral solution, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| EDP-297 | DRUG | EDP-297 Oral solution |
| Placebo | DRUG | placebo to match EDP-297 |
Inclusion Criteria: * 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 65 years, inclusive. Exclusion Criteria: * Clinically relevant evidence or history of illness or disease. * Pregnant or nursing fe...