RecruitingPhase 1NCT07264270

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

Sponsor

Consano Bio

Enrollment

24 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Lumbosacral Radiculopathy Sciatica Sciatic Radiculopathy Lumbosacral Radicular Pain Sciatic Leg Pain Lumbosacral Radicular Syndrome

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

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 Criteria9

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.

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