Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT07264270

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

Led by Consano Bio · Updated on 2026-03-17

24

Participants Needed

3

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of painful lumbosacral radiculopathy (sciatica) with pain radiating to or below the knee, not responding adequately to conservative care
  • Body mass index less than 35 kg/m2
  • Age between 18 and 65 years
  • Both males and females are eligible
Not Eligible

You will not qualify if you...

  • Clinically significant disease or other painful conditions interfering with assessments
  • Need for blood or platelet transfusions
  • Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder
  • Increased risk of bleeding or current use of 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
  • Presence of active malignancy or tumor
  • Prior surgical procedure for back pain
  • Recent use of immunosuppressants, oral steroids, or intravenous steroids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Consano Bio Research Site

Broadmeadow, New South Wales, Australia

Actively Recruiting

2

Consano Bio Research Site

Wahroonga, New South Wales, Australia

Actively Recruiting

3

Consano Bio Research Site

Melbourne, Victoria, Australia

Actively Recruiting

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Research Team

S

Senior Director, Clinical Development Operations

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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