NCT06011317

A Study of EDG-7500 in Healthy Adults

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Edgewise Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The purposes of this Phase 1 study of EDG-7500 are to: 1. Learn about the safety of EDG-7500 after a single and multiple doses in healthy adults 2. Learn about how EDG-7500 is tolerated after a single and multiples doses in healthy adults 3. Evaluate the amount of EDG-7500 is 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-7500 that is in the blood in healthy adults 5. Evaluate whether the amount of EDG-7500 in the blood is similar for the suspension and tablet forms of EDG-7500 in healthy adults Participants will receive a single or multiple doses of EDG-7500 or a placebo by mouth.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	EDG-7500	EDG-7500 is administered orally once daily
DRUG	Placebo	Placebo is administered orally once daily

Timeline

• Start date: 2023-08-14
• Primary completion: 2024-05-23
• Completion: 2024-06-20
• First posted: 2023-08-25
• Last updated: 2024-07-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study