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

Part of paid clinical trials in Napa, California.

Sponsor
Centrexion Therapeutics
Study ID
NCT07122453
Phase
PHASE1
Status
Recruiting
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Conditions

  • Lower Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CNTX-3001 — DRUG
    non-opioid analgesic
  • Placebo — DRUG
    Placebo product

Study Details

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

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CNTX-3001
    Single intrathecal injection of CNTX-3001
  • Placebo Comparator: Placebo
    Single intrathecal injection of normal saline

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NeurovationsNapaCalifornia94558
[email protected]
707-252-9666

Find similar trials in Napa, CA

By research site
Neurovations· Napa, CA

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