Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy

A Phase 1, Randomized, Double-Blind, Single Dose Escalation Study to Assess the Safety and Tolerability of Transforaminal Epidural Administration of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy

The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline

Inclusion Criteria:

• Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
• Body mass index < 35 kg/m2.

Exclusion Criteria:

• Presence of clinically significant disease or any other painful condition that may interfere with assessments.
• Any condition that currently requires blood or platelet transfusions.
• Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder.
• Increased risk of bleeding or is taking anticoagulants or platelet aggregation inhibitors.
• History or presence of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathies.
• History of myocardial infarction within the last 6 months or congestive heart failure.
• The presence of an active malignancy or tumor.
• Have undergone a surgical procedure for back pain.
• Recent use of immunosuppressants, oral steroids, or intravenous steroids.