Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-29 @ 12:22 AM
Study NCT ID:
NCT07177066
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of EDG-15400 in Healthy Adults
Sponsor:
Edgewise Therapeutics, Inc.
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: