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

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

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorConsano Bio

About this trial

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 criteria

Qualifiers

Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care

Body mass index < 35 kg/m2.

Disqualifiers

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.

Trial design

Treatments tested in this trial

C-1101
Placebo: Sterile Saline

Treatment groups

24 Participants

are divided into 3 treatment groups

Locations

Consano Bio Research Site BroadmeadowNew South Wales, Australia

Consano Bio Research Site WahroongaNew South Wales, Australia

Consano Bio Research Site MelbourneVictoria, Australia

Sponsors and collaborators

Consano Bio

Lead sponsor

Source ClinicalTrials.gov