Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain

NCT07122453 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: CNTX-3001it-LBP-1011UG3NS123965-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events

  Number of participants with TEAEs, which includes laboratory test variables

  From baseline to the end of treatment visit (Day 7)

Secondary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of CNTX-3001

  Pre dose to up to 4 hours post dose

• Time to Maximum Observed Plasma Concentration (Tmax) of CNTX-3001

  Pre dose to up to 4 hours post dose

• Area Under the Concentration-time Curve up to the Last Measurable Concentration of CNTX-3001

  Pre dose to up to 4 hours post dose

Study Arms (2)

CNTX-3001

EXPERIMENTAL

Single intrathecal injection of CNTX-3001

Drug: CNTX-3001

Placebo

PLACEBO COMPARATOR

Single intrathecal injection of normal saline

Drug: Placebo

Interventions

CNTX-3001 DRUG

non-opioid analgesic

CNTX-3001

Placebo DRUG

Placebo product

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centrexion Therapeutics: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Neurovations

Napa, California, 94558, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Operations

CONTACT

(617) 837-6911; clinicalops@centrexion.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 14, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)