EDG-15400 for Healthy Adults

Overseen By Contact: Edgewise Therapeutics, Inc.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Edgewise Therapeutics, Inc.

Must not be taking: Prescription medications

Disqualifiers: Substance abuse, Pregnancy, Nicotine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 25 days

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerance of a new treatment called EDG-15400 in healthy adults. Researchers aim to understand how the body processes different forms of this treatment, such as tablets or liquid, and how food affects its absorption. Participants will take either EDG-15400 or a placebo (a substance with no active drug) by mouth, in single or multiple doses. Healthy adults without significant health issues, who are not on certain medications and have not recently donated blood, might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any prescription medications at least 4 weeks before the trial, and any non-prescription medications or supplements 5 days before the trial, unless the protocol allows otherwise.

Is there any evidence suggesting that EDG-15400 is likely to be safe for humans?

Research has shown that EDG-15400 is being tested for safety and tolerability. This early study aims to understand how the drug works in the body. As a Phase 1 trial, it marks the first time EDG-15400 is administered to humans.

Consequently, there is limited information about its safety for people. However, early trials primarily focus on safety, so researchers closely monitor any issues. Participants receive different doses, and researchers carefully check for side effects or problems.

No serious side effects or major safety concerns have been reported so far, suggesting the drug might be well-tolerated at this stage. However, this remains an early study, and further research is necessary to fully understand the safety of EDG-15400. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about EDG-15400 because it offers a potentially innovative approach to drug delivery and absorption in healthy adults. Unlike standard options, which are typically available in fixed formulations, EDG-15400 is being tested in both liquid and solid forms to assess its relative bioavailability. Moreover, the study explores the food effect, comparing how EDG-15400 is absorbed when taken with or without food. These features could lead to more flexible dosing options and improved efficacy, making treatment more adaptable to individual patient needs.

What evidence suggests that EDG-15400 could be effective?

Research shows that EDG-15400 is being tested for safety and tolerability. The study focuses on healthy adults and includes different treatment arms. In Part A, participants receive a single oral ascending dose in a fasted state. Part B involves multiple oral ascending doses once daily in fasted healthy adults. Part C examines the food effect and relative bioavailability with a crossover design, comparing fed versus fasted states and liquid versus solid formulations. Researchers are also studying the drug's pharmacokinetics, assessing how much of the drug enters the blood and how the body processes it. There is no information yet on its efficacy for specific health issues, as the study remains in the early stages. The main goal is to ensure EDG-15400 is safe before testing it for any medical use. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to assess the safety and tolerance of EDG-15400. Participants will be given either the actual drug or a placebo, and their blood and urine levels will be monitored.

Inclusion Criteria

Willing and able to give informed consent and follow all study procedures and requirements

Body mass index (BMI) ≥18.5 to <35 kg/m2; weight ≥55 kg at Screening

I am a healthy adult between 18 and 59 years old.

Exclusion Criteria

Evidence of clinically significant abnormalities or disease

Use of nicotine-containing products in the last 6 months prior to dosing

History of substance abuse or dependency or history of recreational drug use within the last 2 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single or multiple ascending doses of EDG-15400 or placebo

Up to 25 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EDG-15400

Trial Overview The study tests EDG-15400's safety after one or more doses, how well participants tolerate it, its presence in blood/urine over time, the impact of food on its absorption, and compares suspension vs tablet forms.

How Is the Trial Designed?

Group I: Part C: Healthy Adult (Ages ≥18 to <60 years) Food Effect and Relative Bioavailability Experimental Treatment 1 Intervention

Crossover food effect (fed versus fasted) single oral dose in healthy adults and relative bioavailability of liquid versus solid formulation

Group II: Part B: Healthy Adult (Ages ≥18 to <60 years) Multiple Ascending Doses Experimental Treatment 2 Interventions

Multiple oral ascending doses once daily in fasted healthy adults

Group III: Part A: Healthy Adult (Ages ≥18 to <60 years) Single Ascending Dose Experimental Treatment 2 Interventions

Single oral ascending dose in fasted healthy adults

Who Is Running the Clinical Trial?

Edgewise Therapeutics, Inc.

Lead Sponsor

Trials

13

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07177066

NCT07177066 | A Study of EDG-15400 in Healthy Adults A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A ...

2. prnewswire.com prnewswire.com/news-releases/edgewise-therapeutics-reports-third-quarter-2025-financial-results-and-recent-business-highlights-302606313.html

Edgewise Therapeutics Reports Third Quarter 2025 ... EDG-15400 is currently being dosed in healthy adults in a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ...

3. tipranks.com tipranks.com/news/company-announcements/edgewise-therapeutics-advances-with-phase-1-study-of-edg-15400

Edgewise Therapeutics Advances with Phase 1 Study of ... ' The study aims to assess the safety, tolerability, and pharmacokinetics of EDG-15400, a new drug, in healthy adults. This study is significant ...

4. withpower.com withpower.com/trial/phase-1-healthy-adults-7-2025-48fb1

EDG-15400 for Healthy Adults This trial is for healthy adults who can participate in a study to assess the safety and tolerance of EDG-15400. Participants will be given either the actual ...

5. investors.edgewisetx.com investors.edgewisetx.com/financials/quarterly-results/default.aspx

Edgewise Therapeutics, Inc. - Financials - Quarterly Results EDG-15400 is currently being dosed in healthy adults in a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study ...