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

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

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorConsano Bio

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care

Body mass index < 35 kg/m2.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

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

Treatment groups

24 Participants

are divided into 3 treatment groups

Group A: Cohort 1 - Low doseExperimental treatment 2 interventions

Group B: Cohort 2 - Mid doseExperimental treatment 2 interventions

Group C: Cohort 3 - High doseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Incidence and severity of treatment emergent adverse events (TEAEs)

Time frame

From Day 1 to Week 24

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

Time frame

From Day 1 to Week 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Consano Bio

Lead sponsor

Source ClinicalTrials.gov

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