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
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
• Body mass index \< 35 kg/m2.
Locations
Other Locations
Australia
Consano Bio Research Site
RECRUITING
Broadmeadow
Consano Bio Research Site
RECRUITING
Melbourne
Consano Bio Research Site
RECRUITING
Wahroonga
Contact Information
Primary
Senior Director, Clinical Development Operations
clindev@consanobio.com
AUS: +61 (1800) 057510
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 24
Treatments
Experimental: Cohort 1 - Low dose
Experimental: Cohort 2 - Mid dose
Experimental: Cohort 3 - High dose
Related Therapeutic Areas
Sponsors
Leads: Consano Bio