Actively Recruiting
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
Led by Consano Bio · Updated on 2026-03-17
24
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of C-1101 given as a single transforaminal epidural injection in adults with chronic painful lumbosacral radiculopathy, also known as sciatica. This phase 1, randomized, double-blind study compares C-1101 to a placebo (sterile saline) to better understand how patients tolerate this treatment and to monitor for adverse effects. Participants will receive one dose of either C-1101 at varying low, mid, or high doses, or a sterile saline placebo via transforaminal epidural injection. The study includes different cohorts for different dose levels and is designed to observe how the drug behaves in the body and its safety profile compared to the placebo. During the study, participants will be monitored for treatment-emergent adverse events and adverse events of special interest from day 1 through week 24. This includes regular safety assessments to track any side effects or reactions to the injection. The total participation duration spans at least 24 weeks, allowing researchers to collect detailed safety data over time.
CONDITIONS
Brief Title
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
- Body mass index < 35 kg/m2
- Age between 18 and 65 years
- Ability to provide informed consent and comply with study procedures
You will not qualify if you...
- Presence of clinically significant disease or any other painful condition that may interfere with assessments
- Any condition requiring 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 within a defined period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants receive a single dose of C-1101 or sterile saline administered transforaminally to assess safety and tolerability.
1 treatment visit (in-person)
Duration - 24 weeks
Participants are monitored for safety, including adverse events, for 24 weeks after treatment.
Regular follow-up visits over 24 weeks
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
Research Team
S
Senior Director, Clinical Development Operations
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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