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A Study of EDG-15400 in Healthy Adults

NCT07177066 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-09-16

No results posted yet for this study

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 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.

Conditions

  • Healthy Adults

Interventions

DRUG

EDG-15400

EDG-15400 is administered orally

DRUG

Placebo

Placebo is administered orally

Sponsors & Collaborators

  • Edgewise Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07177066 on ClinicalTrials.gov