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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03691623 | A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model | PHASE2 | COMPLETED | 179 | — | — | Oct 15, 2018 | Oct 18, 2019 | May 3, 2022 | 1 | United Kingdom |
Measured in nasal washes by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in participants inoculated with respiratory syncytial virus-A (RSV-A) Memphis 37b.
| Arm | Type | Description |
|---|---|---|
| EDP-938 Arm A | EXPERIMENTAL | Subjects will take EDP-938 Dose 1 oral suspension for 5 days |
| EDP-938 Arm B | EXPERIMENTAL | Subjects will take EDP-938 Dose 2 oral suspension for 5 days |
| Placebo Arm C | PLACEBO_COMPARATOR | Subjects will take matching placebo oral suspension for 5 days |
| EDP-938 Arm D | EXPERIMENTAL | Subjects will take EDP-938 Dose 3 oral suspension for 5 days |
| EDP-938 Arm E | EXPERIMENTAL | Subjects will take EDP-938 Dose 4 oral suspension for 5 days |
| Placebo Arm F | PLACEBO_COMPARATOR | Subjects will take matching placebo oral suspension for 5 days |
| Name | Type | Description |
|---|---|---|
| EDP-938 Dose 1 | DRUG | Oral suspension for 5 days |
| EDP-938 Dose 2 | DRUG | Oral suspension for 5 days |
| Placebo | DRUG | Oral suspension for 5 days |
| EDP-938 Dose 3 | DRUG | Oral suspension for 5 days |
| EDP-938 Dose 4 | DRUG | Oral suspension for 5 days |
Inclusion Criteria: * An informed consent document signed and dated by the subject * Age 18 to 55 years, inclusive * In good health with no history of major medical conditions * A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m\^2 and ≤ 30kg/m\^2 Exclusion Criteria: * Pregnant or nu...