Diabetic Neuropathy Clinical Trial
Official title:
A Phase I Dose-Escalation Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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