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EDG-15400 · 1 trial · 1 indication
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...
EDG-15400 is an investigational small molecule being developed by Edgewise Therapeutics, Inc. (NASDAQ: EWTX). It is currently in Phase 1 clinical development, studied in healthy adult volunteers. As an investigational drug, it has not been approved by regulatory authorities and remains in clinical testing.
EDG-15400 is being studied for use in healthy adults as part of early clinical development. The Phase 1 trial is designed to evaluate the drug in healthy volunteers, which is a standard step before testing in patient populations. Its specific therapeutic indication has not been established.
EDG-15400 is developed by Edgewise Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol EWTX. The company is conducting clinical research on this investigational small molecule in healthy adult volunteers.
EDG-15400 is in Phase 1 clinical development. The Phase 1 trial, which has been completed, enrolled 84 healthy adult participants in the United States. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
EDG-15400 has one completed Phase 1 clinical trial, identified as NCT07177066, titled "A Study of EDG-15400 in Healthy Adults." This randomized, double-blind, controlled study enrolled 84 healthy volunteers aged 18 years and older in the United States.
EDG-15400 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial in healthy adults is part of the early-stage research needed to assess safety and tolerability before any potential approval process.