EDG-15400 safety and dosing in healthy adults

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

This Phase 1 test gives EDG-15400 or placebo to healthy adults to see if it is safe, how well people tolerate it, and how the body absorbs it with different meals and formulations.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: Edgewise Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Tempe, Arizona)
• Trial ID: NCT07177066 on ClinicalTrials.gov

What this trial studies

This Phase 1, placebo-controlled, single- and multiple-ascending dose study gives oral EDG-15400 or placebo to healthy adults to measure safety, tolerability, and pharmacokinetics in blood and urine. The study includes single-dose and multiple-dose periods, a fed-versus-fasted food-effect comparison, and a comparison between suspension and tablet formulations. Participants will undergo physical exams, laboratory tests, ECGs, and timed blood and urine sampling to map drug levels and side effects. The study is conducted at a clinical pharmacology unit in Tempe, Arizona under the sponsorship of Edgewise Therapeutics.

Who should consider this trial

Good fit: Healthy males and nonpregnant females aged 18 to under 60 with BMI 18.5–<35 kg/m2, weight ≥55 kg, no significant medical problems, normal screening labs and ECG, and willingness to follow study procedures are ideal candidates.

Not a fit: People who are pregnant or nursing, have significant health conditions, recent medication use or recent blood loss/donation, or who have breast implants are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could define safe dose ranges, optimal formulation and dosing conditions, and support further testing of EDG-15400 in patient populations.

How similar studies have performed: Phase 1 safety and pharmacokinetic studies in healthy volunteers are a routine and generally successful approach to characterize dose, tolerability, and drug levels, though EDG-15400 itself appears novel with no prior public results.

Eligibility criteria

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 essentially normal physical examination, normal laboratory screening tests, and normal electrocardiogram (ECG) with QTc interval corrected for heart rate using the Fridericia method (QTcF) ≤450 ms.

Exclusion Criteria:

1. Evidence of clinically significant abnormalities or disease.
2. Unless permitted by protocol, use of any prescription medication ≤ 4 weeks or investigational medication ≤ 12 weeks or ≤ 5 half-lives (whichever is longer) of dosing. Use of any non-prescription medication or herbal/nutritional supplement ≤ 5 days prior to dosing.
3. Donation or loss of \> 1 unit (450 mL) of blood ≤ 1 month prior to dosing.
4. Females: nursing, lactating, or pregnant.
5. Females: breast implants.
6. Use of nicotine-containing products in the last 6 months prior to dosing.
7. History of substance abuse or dependency or history of recreational drug use within the last 2 years.
8. Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening.
9. Positive screen for drugs of abuse or alcohol or nicotine exposure test at Screening or Admission.

Additional protocol defined inclusion/exclusion criteria may apply.

Where this trial is running

Tempe, Arizona

• Celerion, Inc. — Tempe, Arizona, United States (Recruiting)

Study contacts

• Study coordinator: Contact: Edgewise Therapeutics, Inc.

Conditions Healthy Adults