Lumbosacral Radicular PainPhase 1NCT07264270
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
A Phase 1 study testing C-1101 in people with Lumbosacral Radicular Pain and Sciatic Radiculopathy, run by Consano Bio at 6 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbosacral Radicular Pain, Sciatic Radiculopathy, Sciatic Leg Pain
- What is being tested?
- C-1101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 3 Dec 2025to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
- Body mass index < 40 kg/m2.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Senior Director, Clinical Development Operations contact
6 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Consano Bio Research Site
Fernandina Beach, Florida, 32034
- Not yet recruiting
Consano Bio Research Site
Richmond, Virginia, 23238
- Recruiting
Consano Bio Research Site
Winston-Salem, North Carolina, 27103
Australia3 sites, 3 recruiting
- Recruiting
Consano Bio Research Site
Broadmeadow, New South Wales
- Recruiting
Consano Bio Research Site
Melbourne, Victoria
- Recruiting
Consano Bio Research Site
Wahroonga, New South Wales
About this study
Official title: 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
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, Lumbosacral Radiculopathy
- Being tested
- C-1101, Placebo: Sterile Saline
- Keywords
- Sciatica, Sciatic Nerve Pain, LSR, back pain, Lumbosacral Radiculopathy, Chronic Painful Lumbosacral Radiculopathy, non-opioid pain medication, transforaminal epidural injection
- Medical subject headings
- Sciatica, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-1101Drug
C-1101
Placebo: Sterile SalineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Low dose | Experimental | Not described Receives: Drug: C-1101; Other: Placebo: Sterile Saline |
| Cohort 2 - Mid dose | Experimental | Not described Receives: Drug: C-1101; Other: Placebo: Sterile Saline |
| Cohort 3 - High dose | Experimental | Not described Receives: Drug: C-1101; Other: Placebo: Sterile Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent adverse events (TEAEs)
Measured: From Day 1 to Week 24
Incidence and severity of adverse events of special interest (AESIs)
Measured: From Day 1 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start3 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral Radicular PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consano Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Consano Chief Medical Officer, Study director, Consano Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264270
- Sponsor's protocol ID
- C-1101-101
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07264270
- Acronym / sponsor ID
- C-1101-101
- Conditions
- Lumbosacral Radicular Pain, Sciatic Radiculopathy, Sciatic Leg Pain, Sciatica, Lumbosacral Radicular Syndrome, Lumbosacral Radiculopathy
- Keywords
- Sciatica, Sciatic Nerve Pain, LSR, back pain, Lumbosacral Radiculopathy, Chronic Painful Lumbosacral Radiculopathy, non-opioid pain medication, transforaminal epidural injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Consano BioIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Low dose | Experimental | Drug: C-1101, Other: Placebo: Sterile Saline |
| Cohort 2 - Mid dose | Experimental | Drug: C-1101, Other: Placebo: Sterile Saline |
| Cohort 3 - High dose | Experimental | Drug: C-1101, Other: Placebo: Sterile Saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
- Body mass index < 40 kg/m2.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-1101C-1101 | Drug | Cohort 1 - Low dose, Cohort 2 - Mid dose, Cohort 3 - High dose |
| Placebo: Sterile SalinePlacebo | Other | Cohort 1 - Low dose, Cohort 2 - Mid dose, Cohort 3 - High dose |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Senior Director, Clinical Development Operations contact
Consano Chief Medical Officer study director
Consano Bio
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C-1101 in people with Lumbosacral Radicular Pain and Sciatic Radiculopathy, run by Consano Bio at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Director, Clinical Development Operations (U.S.:+1-508-492-0599, ClinicalDev@consanobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent adverse events (TEAEs) (time frame: From Day 1 to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.