Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110500
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-05-09
Brief Title:
Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy
Sponsor:
Sangamo Therapeutics
Organization:
Sangamo Therapeutics
Study Overview
Official Title:
A Phase I Dose-Escalation Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection to subjects with diabetic neuropathy
Detailed Description:
Primary objective
To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection To determine the maximum tolerated dose MTD of a single treatment by intramuscular injection by SB-509
Secondary objective
To evaluate the lower extremity clinical effects of SB-509 treatment on lower limb diabetic neuropathy by symptoms neurological examination and lower extremity electrophysiological testing
To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection To determine the maximum tolerated dose MTD of a single treatment by intramuscular injection by SB-509
Secondary objective
To evaluate the lower extremity clinical effects of SB-509 treatment on lower limb diabetic neuropathy by symptoms neurological examination and lower extremity electrophysiological testing
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