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NCT Number: NCT07264270

Study to Evaluate Safety 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

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Key information

Conditions

Lumbosacral Radicular Pain Back Pain Lumbosacral Radicular Syndrome Lumbosacral Radiculopathy Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Leg Pain Sciatic Neuropathy Sciatic Radiculopathy Sciatica Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Consano Bio Research Site, Broadmeadow, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

C-1101

Drug

C-1101

Placebo: Sterile Saline

Other

Placebo

Primary outcomes

  1. Incidence and severity of treatment emergent adverse events (TEAEs)

    Time frame: From Day 1 to Week 24

  2. Incidence and severity of adverse events of special interest (AESIs)

    Time frame: From Day 1 to Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

Senior Director, Clinical Development Operations

CONTACT

[email protected]

AUS: +61 (1800) 057510

Sponsors and collaborators

Lead sponsor

Consano Bio

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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