Recruiting
Phase 1

C-1101

Sponsor:

Consano Bio

Code:

NCT07264270

Conditions

Lumbosacral Radicular Pain

Sciatic Radiculopathy

Sciatic Leg Pain

Sciatica

Lumbosacral Radicular Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

C-1101

Placebo: Sterile Saline

Study Details

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 Pain

Sciatic Radiculopathy

Sciatic Leg Pain

Sciatica

Lumbosacral Radicular Syndrome

Study ID

NCT07264270

Start date

Dec 3, 2025

Status verified date

Oct, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
  • Body mass index < 40 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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 - Low dose

experimental: Cohort 2 - Mid dose

experimental: Cohort 3 - High dose

Interventions

C-1101

C-1101

Placebo: Sterile Saline

Placebo

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Senior Director, Clinical Development Operations

U.S.:+1-508-492-0599ClinicalDev@consanobio.com

AUS Clinical Development Operations

AUS: +61 8 8361 3222ClinicalDev@consanobio.com

Locations

Consano Bio Research Site

Recruiting

Fernandina Beach, Florida, United States, 32034

Consano Bio Research Site

Recruiting

Winston-Salem, North Carolina, United States, 27103

More Information

Sponsor

Consano Bio

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Consano Bio on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.