Lower Back PainPhase 1NCT07122453
Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
A Phase 1 study testing CNTX-3001 in people with Lower Back Pain, run by Centrexion Therapeutics at 1 site in United States.
Trial summary
This clinical study is being conducted to evaluate the safety, tolerability, plasma pharmacokinetics and efficacy of an investigational drug called CNTX-3001. This Phase 1 study is the first time that CNTX-3001 will be given to people (first-in-human study). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- CNTX-3001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2026to Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have stable intractable, chronic moderate to severe low back pain
- Must have failed all 3 of the following categories of therapies:
- Physical medicine modalities for at least 6 weeks (e.g., physical therapy, occupational therapy, or chiropractic treatment directed at chronic low back pain)
- Three or more classes of pharmacologic treatments
- One or more non-surgical and/or surgical interventions addressing the primary cause of chronic low back pain
- If the intractable low back pain is accompanied by radicular pain, back pain must be dominant over leg pain and may not radiate below the knee
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- Has normal leg strength in both legs (able to stand/walk)
- Willing and able to undergo the lumbar puncture
- On a stable analgesic regimen, or a stable dose of an opioid medication for >3 months
- Non- or ex-smoker and has not used any nicotine-containing products within 3 months
- Men or women able to abide by reproductive and contraceptive requirements
- Has a body mass index (BMI) between 18 and 35 kg/m2, with weight ≥60 kg
Who cannot join
- Substantial increase or decrease in pain over the prior 3 months.
- Low back pain that only occurs with specific activities or body positions.
- Has asthma or other severe respiratory disease requiring daily prescription medication
- History of, or current cancer (except basal cell carcinoma), cardiac disease, immunological disorders, meningitis, or bleeding disorders
- Confirmed diagnosis of fibromyalgia or myalgic encephalomyelitis
- Substantial increase or decrease in pain over the prior 3 months
Show all 10Show fewer
- Low back pain that only occurs with specific activities or body positions
- Has asthma or other severe respiratory disease requiring daily prescription medication
- History of, or current cancer (except basal cell carcinoma), cardiac disease, immunological disorders, meningitis, or bleeding disorders
- Confirmed diagnosis of fibromyalgia or myalgic encephalomyelitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Neurovations
Napa, California, 94558
707-252-9666, info@neurovations.com
About this study
Official title: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Single Ascending Doses of Intrathecal CNTX-3001 in Subjects With Intractable Chronic Moderate to Severe Low Back Pain
This clinical study is being conducted to evaluate the safety, tolerability, plasma pharmacokinetics and efficacy of an investigational drug called CNTX-3001. This Phase 1 study is the first time that CNTX-3001 will be given to people (first-in-human study). The study is being done to evaluate whether CNTX-3001, given into the intrathecal space by lumbar puncture, can be administered safely to participants who have been diagnosed with intractable chronic moderate to severe low back pain and who have not responded well to other treatments in the past.
CNTX-3001 is a novel, non-opioid small molecule
- Conditions
- Lower Back Pain
- Being tested
- CNTX-3001, Placebo
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTX-3001Drug
non-opioid analgesic
PlaceboDrug
Placebo product
| Study group | Role | What they receive |
|---|---|---|
| CNTX-3001 | Experimental | Single intrathecal injection of CNTX-3001 Receives: Drug: CNTX-3001 |
| Placebo | Placebo comparator | Single intrathecal injection of normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Number of participants with TEAEs, which includes laboratory test variables
Measured: From baseline to the end of treatment visit (Day 7)
Secondary outcomes (3)
Maximum Observed Plasma Concentration (Cmax) of CNTX-3001
Measured: Pre dose to up to 4 hours post dose
Time to Maximum Observed Plasma Concentration (Tmax) of CNTX-3001
Measured: Pre dose to up to 4 hours post dose
Area Under the Concentration-time Curve up to the Last Measurable Concentration of CNTX-3001
Measured: Pre dose to up to 4 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study startMar 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centrexion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122453
- Sponsor's protocol ID
- CNTX-3001it-LBP-101
- Other IDs
- 1UG3NS123965-01
- Status last verified
- Mar 2026
- First submitted
- 3 Jul 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Single Ascending Doses of Intrathecal CNTX-3001 in Subjects With Intractable Chronic Moderate to Severe Low Back Pain
- ClinicalTrials.gov ID
- NCT07122453
- Acronym / sponsor ID
- CNTX-3001it-LBP-101
- Conditions
- Lower Back Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Aug 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.
This clinical study is being conducted to evaluate the safety, tolerability, plasma pharmacokinetics and efficacy of an investigational drug called CNTX-3001. This Phase 1 study is the first time that CNTX-3001 will be given to people (first-in-human study). The study is being done to evaluate whether CNTX-3001, given into the intrathecal space by lumbar puncture, can be administered safely to participants who have been diagnosed with intractable chronic moderate to severe low back pain and who have not responded well to other treatments in the past.
CNTX-3001 is a novel, non-opioid small molecule
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNTX-3001 | Experimental | Drug: CNTX-3001Single intrathecal injection of CNTX-3001 |
| Placebo | Placebo comparator | Drug: PlaceboSingle intrathecal injection of normal saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have stable intractable, chronic moderate to severe low back pain
- Must have failed all 3 of the following categories of therapies:
- If the intractable low back pain is accompanied by radicular pain, back pain must be dominant over leg pain and may not radiate below the knee
- Has normal leg strength in both legs (able to stand/walk)
- Willing and able to undergo the lumbar puncture
Key exclusion criteria (10 listed)
- Substantial increase or decrease in pain over the prior 3 months.
- Low back pain that only occurs with specific activities or body positions.
- Has asthma or other severe respiratory disease requiring daily prescription medication
- History of, or current cancer (except basal cell carcinoma), cardiac disease, immunological disorders, meningitis, or bleeding disorders
- Confirmed diagnosis of fibromyalgia or myalgic encephalomyelitis
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 |
|---|---|---|
| CNTX-3001non-opioid analgesic | Drug | CNTX-3001 |
| PlaceboPlacebo product | Drug | Placebo |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: From baseline to the end of treatment visit (Day 7)
Number of participants with TEAEs, which includes laboratory test variables
3 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of CNTX-3001
Time frame: Pre dose to up to 4 hours post dose
Time to Maximum Observed Plasma Concentration (Tmax) of CNTX-3001
Time frame: Pre dose to up to 4 hours post dose
Area Under the Concentration-time Curve up to the Last Measurable Concentration of CNTX-3001
Time frame: Pre dose to up to 4 hours post dose
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 23 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNTX-3001 in people with Lower Back Pain, run by Centrexion Therapeutics at 1 site in United States.
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 12 inclusion and 10 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 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 Clinical Operations ((617) 837-6911, clinicalops@centrexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (time frame: From baseline to the end of treatment visit (Day 7)). 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 23 Mar 2026.