Actively Recruiting
Phase 1 Study to Test Safety of Single Dose C-1101 Injection 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
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
Research Team
S
Senior Director, Clinical Development Operations
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