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

March 16, 2026 updated by: Consano Bio

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Senior Director, Clinical Development Operations
  • Phone Number: AUS: +61 (1800) 057510
  • Email: clindev@consanobio.com

Study Locations

  • Australia
    • New South Wales
      • Broadmeadow, New South Wales, Australia
        • Recruiting
        • Consano Bio Research Site
      • Wahroonga, New South Wales, Australia
        • Recruiting
        • Consano Bio Research Site
    • Victoria
      • Melbourne, Victoria, Australia
        • Recruiting
        • Consano Bio Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
  • Body mass index < 35 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - Low dose
Drug: C-1101
C-1101
Other: Placebo: Sterile Saline
Placebo
Experimental: Cohort 2 - Mid dose
Drug: C-1101
C-1101
Other: Placebo: Sterile Saline
Placebo
Experimental: Cohort 3 - High dose
Drug: C-1101
C-1101
Other: Placebo: Sterile Saline
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of treatment emergent adverse events (TEAEs)
Time Frame: From Day 1 to Week 24
From Day 1 to Week 24
Incidence and severity of adverse events of special interest (AESIs)
Time Frame: From Day 1 to Week 24
From Day 1 to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consano Bio

Investigators

  • Study Director: Consano Chief Medical Officer, Consano Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-1101-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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