Safety of a single transforaminal C-1101 injection versus saline for chronic sciatica

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

This will test whether a single transforaminal epidural injection of C-1101 is safe and well tolerated compared with sterile saline in adults with chronic sciatica who have not improved with conservative care.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Consano Bio (industry)
• Locations: 3 sites (Broadmeadow, New South Wales and 2 other locations)
• Trial ID: NCT07264270 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized interventional trial compares a single transforaminal epidural dose of C-1101 to sterile saline with a primary focus on safety and tolerability. Eligible adults have lumbosacral radicular pain (sciatica) radiating at or below the knee and an inadequate response to conservative treatments, with body mass index under 35 kg/m2. Important exclusions include bleeding risk or anticoagulant use, peripheral neuropathies, recent major cardiac events, active malignancy, prior back surgery, recent systemic immunosuppression or steroids, and certain psychiatric diagnoses. The study is being conducted at Consano Bio research sites in Australia and uses a placebo-controlled design to isolate safety signals.

Who should consider this trial

Good fit: Adults with chronic lumbosacral radicular pain radiating to or below the knee who have not improved with conservative care and meet medical criteria (including BMI <35 and no bleeding risk, neuropathy, recent steroids, or prior back surgery) are the ideal candidates.

Not a fit: Patients with other significant painful conditions, peripheral neuropathies, active cancer, recent major cardiac events, those on anticoagulants or requiring transfusions, recent steroid/immunosuppressant use, or prior back surgery are excluded and therefore unlikely to benefit from participation.

Why it matters

Potential benefit: If shown safe and tolerable, C-1101 could be developed further as a new injectable option to treat radicular leg pain from sciatica.

How similar studies have performed: Epidural injections (e.g., steroids, local anesthetics) have shown mixed short-term benefit for radicular pain in prior research, while C-1101 itself appears to be a novel agent without established clinical efficacy for this indication.

Eligibility criteria

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.

Where this trial is running

Broadmeadow, New South Wales and 2 other locations

• Consano Bio Research Site — Broadmeadow, New South Wales, Australia (RECRUITING)
• Consano Bio Research Site — Wahroonga, New South Wales, Australia (RECRUITING)
• Consano Bio Research Site — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Senior Director, Clinical Development Operations

Conditions: Lumbosacral Radicular Pain, Sciatic Radiculopathy, Sciatic Leg Pain, Sciatica, Lumbosacral Radicular Syndrome, Lumbosacral Radiculopathy, Sciatic Nerve Pain, LSR