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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07177066 | A Study of EDG-15400 in Healthy Adults | PHASE1 | RECRUITING | 108 | — | — | Aug 20, 2025 | May 1, 2026 | Sep 16, 2025 | 1 | United States |
To determine the safety and tolerability of EDG-15400 when administered as single and multiple ascending doses to healthy adults
| Arm | Type | Description |
|---|---|---|
| Part A: Healthy Adult (Ages ≥18 to <60 years) Single Ascending Dose | EXPERIMENTAL | Single oral ascending dose in fasted healthy adults |
| Part B: Healthy Adult (Ages ≥18 to <60 years) Multiple Ascending Doses | EXPERIMENTAL | Multiple oral ascending doses once daily in fasted healthy adults |
| Part C: Healthy Adult (Ages ≥18 to <60 years) Food Effect and Relative Bioavailability | EXPERIMENTAL | Crossover food effect (fed versus fasted) single oral dose in healthy adults and relative bioavailability of liquid versus solid formulation |
| Name | Type | Description |
|---|---|---|
| EDG-15400 | DRUG | EDG-15400 is administered orally |
| Placebo | DRUG | Placebo is administered orally |
Inclusion Criteria: 1. Willing and able to give informed consent and follow all study procedures and requirements. 2. Healthy male or nonpregnant female, ages ≥18 to \<60 years. 3. Body mass index (BMI) ≥18.5 to \<35 kg/m2; weight ≥55 kg at Screening. 4. Absence of important health problems and ess...