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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-12-01

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 - Low dose

Group Type EXPERIMENTAL

C-1101

Intervention Type DRUG

C-1101

Placebo: Sterile Saline

Intervention Type OTHER

Placebo

Cohort 2 - Mid dose

Group Type EXPERIMENTAL

C-1101

Intervention Type DRUG

C-1101

Placebo: Sterile Saline

Intervention Type OTHER

Placebo

Cohort 3 - High dose

Group Type EXPERIMENTAL

C-1101

Intervention Type DRUG

C-1101

Placebo: Sterile Saline

Intervention Type OTHER

Placebo

Interventions

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C-1101

Intervention Type DRUG

Placebo: Sterile Saline

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No