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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07482657 | A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus | PHASE2 | NOT YET_RECRUITING | 150 | — | — | Jul 1, 2026 | Dec 1, 2026 | Mar 19, 2026 | - | — |
| NCT06601192 | A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults | PHASE1 | COMPLETED | 72 | — | — | Jul 15, 2024 | Feb 25, 2025 | Jul 28, 2025 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| zelicapavir | EXPERIMENTAL | zelicapavir, oral suspension, once daily for 7 days |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 7 days |
| zelicapavir Dose 1 (therapeutic dose) | EXPERIMENTAL | All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25. |
| zelicapavir Dose 2 (supratherapeutic dose) | EXPERIMENTAL | All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25. |
| moxifloxacin | EXPERIMENTAL | All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25. |
| Name | Type | Description |
|---|---|---|
| zelicapavir | DRUG | Oral suspension |
| Placebo | DRUG | Placebo oral suspension to match zelicapavir |
| zelicapavir (therapeutic dose) | DRUG | Subjects will receive zelicapavir (TD) once per treatment period. |
| zelicapavir (supratherapeutic dose) | DRUG | Subjects will receive zelicapavir (SD) once per treatment period. |
| moxifloxacin | DRUG | Subjects will receive moxifloxin once per treatment period. |
Inclusion Criteria: * Participants diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection with SARS-CoV-2 or influenza * Participant has signs of RSV infection with onset ≤3 days (72 hours) at the time of randomization * In the Investigator's op...