Status:
RECRUITING
A Study of EDG-15400 in Healthy Adults
Lead Sponsor:
Edgewise Therapeutics, Inc.
Conditions:
Healthy Adults
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Willing and able to give informed consent and follow all study procedures and requirements.
- Healthy male or nonpregnant female, ages ≥18 to \<60 years.
- Body mass index (BMI) ≥18.5 to \<35 kg/m2; weight ≥55 kg at Screening.
- 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
- Evidence of clinically significant abnormalities or disease.
- 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.
- Donation or loss of \> 1 unit (450 mL) of blood ≤ 1 month prior to dosing.
- Females: nursing, lactating, or pregnant.
- Females: breast implants.
- 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.
- Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening.
- Positive screen for drugs of abuse or alcohol or nicotine exposure test at Screening or Admission.
- Additional protocol defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
August 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT07177066
Start Date
August 20 2025
End Date
May 1 2026
Last Update
September 16 2025
Active Locations (1)
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1
Celerion, Inc.
Tempe, Arizona, United States, 85283