Trials / Completed
CompletedNCT00110500
Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy
A Phase I Dose-Escalation Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Sangamo Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | hVEGF-A |
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2008-01-01
- Completion
- 2008-01-01
- First posted
- 2005-05-10
- Last updated
- 2011-06-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00110500. Inclusion in this directory is not an endorsement.