A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults

Part of paid clinical trials in Glendale, California.

Sponsor
Edgewise Therapeutics, Inc.
Study ID
NCT07456059
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • EDG-7500 — DRUG
    Solid oral formulation of EDG-7500

Study Details

The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study.

Key Dates

Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort 1 - Healthy Japanese Adults
    Single and Multiple Dose EDG-7500
  • Experimental: Cohort 2 - Healthy Japanese Adults
    Single and Multiple Dose EDG-7500
  • Experimental: Cohort 3 - Healthy Caucasian Adults
    Single and Multiple Dose EDG-7500

Primary Outcome Measure

AUC0-last [ Time Frame: Day 1 to Day 13 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ParexelGlendaleCalifornia91206
Edgewise Therapeutics, Inc.
720-262-7002

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