Recruiting
Phase 1

CNTX-3001

Sponsor:

Centrexion Therapeutics

Code:

NCT07122453

Conditions

Lower Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CNTX-3001

Placebo

Study Details

Brief 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). 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

Study ID

NCT07122453

Start date

Mar, 2026

Status verified date

Mar, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion:

  • Have stable intractable, chronic moderate to severe low back pain
  • Must have failed all 3 of the following categories of therapies:

1. Physical medicine modalities for at least 6 weeks (e.g., physical therapy, occupational therapy, or chiropractic treatment directed at chronic low back pain)
2. Three or more classes of pharmacologic treatments
3. 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
  • 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

Exclusion

  • 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

Exclusion

  • 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

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CNTX-3001

Single intrathecal injection of CNTX-3001

placebo comparator: Placebo

Single intrathecal injection of normal saline

Interventions

CNTX-3001

non-opioid analgesic

Placebo

Placebo product

Primary outcome measure

  • Incidence of treatment emergent adverse events [ Time Frame: From baseline to the end of treatment visit (Day 7) ]

Central Contacts and Locations

Central contacts

Clinical Operations

(617) 837-6911clinicalops@centrexion.com

Locations

Neurovations

Recruiting

Napa, California, United States, 94558

Contacts

707-252-9666info@neurovations.com

More Information

Sponsor

Centrexion Therapeutics

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centrexion Therapeutics on 2026-03-23.