Edgewise Therapeutics, Inc. ((EWTX)) announced an update on their ongoing clinical study.
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Edgewise Therapeutics, Inc. is conducting a Phase 1 study titled ‘A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Healthy Adults.’ The study aims to assess the safety, tolerability, and pharmacokinetics of EDG-15400, a new drug, in healthy adults. This study is significant as it explores the foundational safety and dosage parameters for future clinical applications.
The intervention being tested is EDG-15400, administered orally in both single and multiple doses, with a placebo group for comparison. The study also examines the drug’s bioavailability in different formulations and its interaction with food intake.
The study design is interventional, randomized, and triple-masked, meaning participants, care providers, and investigators are unaware of the group assignments. It follows a sequential intervention model with a primary purpose of basic science, focusing on understanding the drug’s effects and safety.
The study began on August 27, 2025, with the latest update submitted on September 12, 2025. These dates are crucial as they mark the study’s progression and ensure stakeholders are informed of its current status.
For investors, the ongoing study of EDG-15400 could influence Edgewise Therapeutics’ stock performance, as positive results may boost investor confidence and market value. Understanding the competitive landscape and potential advancements in drug safety and efficacy can provide valuable insights into the company’s future growth prospects.
The study is currently recruiting, with further details available on the ClinicalTrials portal.