Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Lumbosacral Radicular Pain, Sciatic Radiculopathy, Sciatic Leg Pain, Sciatica, Lumbosacral Radicular Syndrome, Lumbosacral Radiculopathy
In brief
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
Key facts
- Study ID
- NCT07264270
- Run by
- Consano Bio
- People needed
- 24
- Starts
- 2025-12-03
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-03-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
- Body mass index < 35 kg/m2.
You may not qualify if…
- 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.
Where it is running
- Consano Bio Research Site — Broadmeadow, New South Wales, Australia (enrolling)
- Consano Bio Research Site — Wahroonga, New South Wales, Australia (enrolling)
- Consano Bio Research Site — Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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