Ignite Creation Date:
2024-05-06 @ 12:47 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01651234
Status:
COMPLETED
Last Update Posted:
2012-08-29
First Post:
2012-07-17
Brief Title:
A Study to Assess Safety Tolerability and Pharmacokinetics of Orally Administered GCC4401C in Healthy Volunteers
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Placebo-controlled Single Ascending Dose Study Evaluating the Safety Tolerability and Pharmacokinetics of Orally Administered GCC-4401C in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2012-08
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 this study is to evaluate the safety tolerability and characterize the PK PD fprofile
Detailed Description:
The primary objective of this study is to investigate the safety and tolerability following administration of single ascending doses of GCC4401C in healthy male subjects and the secondary objective of this study is to characterize the single-dose PK profile after oral administration of GCC-4401C and to determine an appropriate dose range and dosing regimen of oral GCC-4401C for subsequent clinical trials
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?:
None