ClinicalTrials.gg
RecruitingNCT07264270Updated Oct 21, 2026

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

A Phase 1 interventional study of C-1101 and Placebo: Sterile Saline in Lumbosacral Radicular Pain, Sciatic Radiculopathy and Sciatic Leg Pain, sponsored by Consano Bio. Recruiting at 6 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Consano Bio · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Updated Oct 21, 2026First site in United StatesPrimary completion moved+4 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

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

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Keywords

  • Sciatica
  • Sciatic Nerve Pain
  • LSR
  • back pain
  • Lumbosacral Radiculopathy
  • Chronic Painful Lumbosacral Radiculopathy
  • non-opioid pain medication
  • transforaminal epidural injection
03

In context

Sciatica

149 studies on the registry are indexed under Sciatica; 31 are open to participants now.

This study's planned enrollment of 24 is below the median of 68 across 122 interventional studies indexed under Sciatica.

Browse Sciatica studies →

Lead sponsor

This is the only study on the registry with Consano Bio as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 21, 2026. See what changed

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
  • \< 40 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • Presence of disease or any other painful condition that may interfere with assessments.
  • Any condition that currently requires blood or 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 or tumor.
  • Have undergone a surgical procedure for back pain.
  • Recent use of , oral , or intravenous steroids.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Cohort 1 - Low dose

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

  • Experimental
    Cohort 2 - Mid dose

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

  • Experimental
    Cohort 3 - High dose

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

Interventions

  • DrugC-1101

    C-1101

  • OtherPlacebo: Sterile Saline

    Placebo

06

What researchers measure

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

07

Study locations

5 of 6 sites recruiting
  • Consano Bio Research Site
    Fernandina Beach, Florida 32034, United States
    Recruiting
  • Consano Bio Research Site
    Winston-Salem, North Carolina 27103, United States
    Recruiting
  • Consano Bio Research Site
    Richmond, Virginia 23238, United States
    Not yet recruiting
  • Consano Bio Research Site
    Broadmeadow, New South Wales, Australia
    Recruiting
  • Consano Bio Research Site
    Wahroonga, New South Wales, Australia
    Recruiting
  • Consano Bio Research Site
    Melbourne, Victoria, Australia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Dec 2025 (actual). Primary completion is estimated for Jun 2027, 18 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: primary completion Nov 2026 → Jun 2027 and completion Dec 2026 → Jun 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2025
First posted
Dec 4, 2025
StartActual
Dec 3, 2025
Primary completionEst.
Jun 2027was Nov 2026
CompletionEst.
Jun 2027was Dec 2026
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added — first site in United States
Show 3 added (3 United States)
  • Consano Bio Research Site · Fernandina Beach, United States
  • Consano Bio Research Site · Winston-Salem, United States
  • Consano Bio Research Site · Richmond, United States
Oct 21, 2026
Primary completion
Nov 1, 2026→Jun 2027
Oct 21, 2026
Study completion
Dec 1, 2026→Jun 2027
Oct 21, 2026
Eligibility
Maximum age 65 Years→70 Years; 1 inclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedBody mass index < 3540 kg/m2.
Oct 21, 2026
Contact
Study contact changed: •••7510→•••0599; c•••@consanobio.com→C•••@consanobio.com; added C•••@consanobio.com · •••3222. See the current contact
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    3 sites added — first site in United States
    Show 3 added (3 United States)
    • Consano Bio Research Site · Fernandina Beach, United States
    • Consano Bio Research Site · Winston-Salem, United States
    • Consano Bio Research Site · Richmond, United States
    Primary completion Nov 1, 2026→Jun 2027
    Study completion Dec 1, 2026→Jun 2027
    Eligibility Maximum age 65 Years→70 Years; 1 inclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedBody mass index < 3540 kg/m2.
    Contact Study contact changed: •••7510→•••0599; c•••@consanobio.com→C•••@consanobio.com; added C•••@consanobio.com · •••3222. See the current contact
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07264270
Lead sponsor
Consano Bio
Responsible party
Sponsor
First posted
Dec 4, 2025
Start date
Dec 3, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Senior Director, Clinical Development Operations
Contact
ClinicalDev@consanobio.com
U.S.:+1-508-492-0599
AUS Clinical Development Operations
Contact
ClinicalDev@consanobio.com
AUS: +61 8 8361 3222
Consano Chief Medical Officer
study director · Consano Bio

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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