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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02652377 | EDP-494-001: A Study of EDP-494 in Healthy Subjects and Hepatitis C Patients | PHASE1 | COMPLETED | 100 | — | — | Jan 10, 2016 | Dec 27, 2016 | Jan 23, 2017 | 1 | New Zealand |
Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine). Administered to healthy volunteers and multiple doses of EDP-494 administered to healthy volunteers and subjects with Chronic Hepatitis C (CHC) genotype 1 and 3 infection
| Arm | Type | Description |
|---|---|---|
| EDP-494 SAD Cohorts | EXPERIMENTAL | EDP-494, oral 50 mg, 100mg, 200mg, 400mg and 800 mg, capsules, once daily in one single administration |
| EDP-494 MAD/POC Cohorts | EXPERIMENTAL | EDP-494, oral 200mg, 400mg and 800 mg, capsules, once daily for 14 days |
| EDP-494 SAD Placebo Cohort | PLACEBO_COMPARATOR | - |
| EDP-494 MAD/POC Placebo Cohort | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| EDP-494 | DRUG | 10, 100 and 200 mg capsules |
| Placebo | DRUG | placebo to match EDP-494 |
Inclusion Criteria for Healthy Volunteers (SAD and MAD Phases): * 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 who have not had a vasectomy must use effective co...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | — | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | — | Undisclosed |