A Study of EDG-15400 in Healthy Adults

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Edgewise Therapeutics, Inc.
Study ID
NCT07177066
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Adults

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Accepted

Interventions

  • EDG-15400 — DRUG
    EDG-15400 is administered orally
  • Placebo — DRUG
    Placebo is administered orally

Study Details

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 and multiples doses in healthy adults 3. Evaluate the amount of EDG-15400 in the blood and urine after single and multiple doses in healthy adults 4. Evaluate the effect of a meal on the amount of EDG-15400 that is in the blood in healthy adults 5. Evaluate whether the amount of EDG-15400 in the blood is similar for the suspension and tablet forms of EDG-15400 in healthy adults Participants will receive a single or multiple doses of EDG-15400 or a placebo by mouth.

Key Dates

Start date
Aug 20, 2025
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part A: Healthy Adult (Ages ≥18 to <60 years) Single Ascending Dose
    Single oral ascending dose in fasted healthy adults
  • Experimental: Part B: Healthy Adult (Ages ≥18 to <60 years) Multiple Ascending Doses
    Multiple oral ascending doses once daily in fasted healthy adults
  • Experimental: Part C: Healthy Adult (Ages ≥18 to <60 years) Food Effect and Relative Bioavailability
    Crossover food effect (fed versus fasted) single oral dose in healthy adults and relative bioavailability of liquid versus solid formulation

Primary Outcome Measure

Safety: incidence of treatment-emergent adverse events [ Time Frame: Up to 25 days of monitoring ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, Inc.TempeArizona85283
Edgewise Therapeutics, Inc.
720-262-7002

Find similar trials in Tempe, AZ

By research site
Celerion, Inc.· Tempe, AZ

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