Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-29 @ 9:44 AM
Study NCT ID:
NCT07081503
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of ADX-626 in Healthy Participants
Sponsor:
ADARx Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2025-12
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:
ADX-626-101
Brief Summary:
This first-in-human study will evaluate the safety and tolerability of ADX-626 in healthy participants. The study will also look at how ADX-626 interacts with the human body (the pharmacokinetics and pharmacodynamics of ADX-626).
Detailed Description:
A Phase 1, first-in-human study to assess the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-626 compared with placebo in healthy participants.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: