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Recruiting Phase 1 NCT07264270

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

Phase 1 – testing safety in a small group of people
Conditions: Lumbosacral Radicular Pain Sciatic Radiculopathy Sciatic Leg Pain Sciatica Lumbosacral Radicular Syndrome Lumbosacral Radiculopathy

Sponsor: Consano Bio

trial.available_in: БГ
Overview
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
Who can participate
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.
Locations 1
Australia (1)
Consano Bio Research Site
Broadmeadow , New South Wales
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
03.12.2025
Completion date
01.12.2026
Registry ID
NCT07264270
Source
anzctr
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