Ignite Creation Date:
2025-12-18 @ 8:11 AM
Ignite Modification Date:
2025-12-18 @ 8:11 AM
Study NCT ID:
NCT03099824
Status:
None
Last Update Posted:
2021-03-02 00:00:00
First Post:
2017-03-20 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy Volunteers
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase 1, Open-label Study to Compare the Safety and Pharmacokinetics of Various Formulations of Orally Administered Superoxide Dismutase Mimetic GC4711 With Intravenously Administered Superoxide Dismutase Mimetic GC4419 or GC4711 in Healthy Volunteers
Status:
None
Status Verified Date:
2021-03
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 purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous infusion.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: