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

Consano Bio

Status and phase: Enrolling; Phase 1

Conditions: Lumbosacral Radicular Pain; Sciatic Leg Pain; Sciatic Radiculopathy; Lumbosacral Radiculopathy; Sciatica; Lumbosacral Radicular Syndrome

Treatments: Drug: C-1101; Other: Placebo: Sterile Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT07264270

C-1101-101

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Cohort 1 - Low dose

Experimental group

Treatment:

Other: Placebo: Sterile Saline

Drug: C-1101

Cohort 2 - Mid dose

Experimental group

Treatment:

Other: Placebo: Sterile Saline

Drug: C-1101

Cohort 3 - High dose

Experimental group

Treatment:

Other: Placebo: Sterile Saline

Drug: C-1101