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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07540910 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults | PHASE1 | RECRUITING | 98 | — | — | Apr 1, 2026 | Nov 1, 2026 | Apr 21, 2026 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| EDP-978 SAD Cohorts | EXPERIMENTAL | EDP-978 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6 and Dose 7, orally daily in one single administration |
| EDP-978 MAD Cohorts | EXPERIMENTAL | EDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days |
| EDP-978 SAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily in one single administration |
| EDP-978 MAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| EDP-978 | DRUG | Oral administration |
| Placebo | DRUG | Placebo to match EDP-978, oral administration |
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. * Infection with human i...