The purposes of this Phase 1 study of EDG-15400 are to: 1. Learn about the safety of EDG-15400 after single and multiple doses in healthy adults 2. Learn about how EDG-15400 is tolerated after single and multiples doses in healthy adults 3. Evaluate the amount of EDG-15400 in the blood and urine after single and multiple doses in healthy adults 4. Evaluate the effect of a meal on the amount of EDG-15400 that is in the blood in healthy adults 5. Evaluate whether the amount of EDG-15400 in the blood is similar for the suspension and tablet forms of EDG-15400 in healthy adults Participants will receive a single or multiple doses of EDG-15400 or a placebo by mouth.
Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.
Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.
Edgewise Therapeutics (EWTX) is the sponsoring company for this trial. BiotechSign currently grades this company D (43/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.