Home › Sciatica › NCT07264270

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

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

Who can join

Ages 18 to 70 · All sexes

Inclusion Criteria:

* Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
* Body mass index \< 40 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.

About the study

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

What is being tested

• C-1101 (drug)
• Placebo: Sterile Saline (other)

Sponsor: Consano Bio · Participants: 24 · Started: Dec 3, 2025

Contact the study team

• Senior Director, Clinical Development Operations · Phone: U.S.:+1-508-492-0599
• AUS Clinical Development Operations · Phone: AUS: +61 8 8361 3222

Official record on ClinicalTrials.gov — NCT07264270

Locations in the U.S.

Conditions

• Sciatica
• Back Pain

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.