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

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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07264270

Enrollment

Registered

2025-12-04

Start date

2025-12-03

Completion date

2026-12-01

Last updated

2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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

Interventions

DRUGC-1101

C-1101

OTHERPlacebo: Sterile Saline

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Australia

Contacts

CONTACTSenior Director, Clinical Development Operations

clindev@consanobio.comAUS: +61 (1800) 057510

STUDY_DIRECTORConsano Chief Medical Officer

Consano Bio

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026