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

NCT07264270 | Recruiting Phase 1

• 1 other identifier: C-1101-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Lumbosacral Radicular Syndrome; Lumbosacral Radiculopathy; Lumbosacral Radicular Pain; Sciatic Radiculopathy; Sciatic Leg Pain; Sciatica

Keywords

Sciatica; Sciatic Nerve Pain; LSR; back pain; Lumbosacral Radiculopathy; Chronic Painful Lumbosacral Radiculopathy; non-opioid pain medication; transforaminal epidural injection

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of treatment emergent adverse events (TEAEs)

  From Day 1 to Week 24

• Incidence and severity of adverse events of special interest (AESIs)

  From Day 1 to Week 24

Study Arms (3)

Cohort 1 - Low dose

EXPERIMENTAL

Drug: C-1101; Other: Placebo: Sterile Saline

Cohort 2 - Mid dose

EXPERIMENTAL

Drug: C-1101; Other: Placebo: Sterile Saline

Cohort 3 - High dose

EXPERIMENTAL

Drug: C-1101; Other: Placebo: Sterile Saline

Interventions

C-1101 DRUG

C-1101

Cohort 1 - Low dose; Cohort 2 - Mid dose; Cohort 3 - High dose

Placebo: Sterile Saline OTHER

Placebo

Cohort 1 - Low dose; Cohort 2 - Mid dose; Cohort 3 - High dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
• Body mass index \< 35 kg/m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consano Bio: lead

Study Sites (3)

Consano Bio Research Site

Broadmeadow, New South Wales, Australia

RECRUITING

Consano Bio Research Site

Wahroonga, New South Wales, Australia

RECRUITING

Consano Bio Research Site

Melbourne, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Sciatica; Back Pain

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Consano Chief Medical Officer

  Consano Bio

  STUDY DIRECTOR

Central Study Contacts

Senior Director, Clinical Development Operations

CONTACT

AUS: +61 (1800) 057510; clindev@consanobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 4, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)