Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
- Conditions
- Lower Back Pain
- Interventions
- Drug: CNTX-3001Drug: Placebo
- Registration Number
- NCT07122453
- Lead Sponsor
- Centrexion Therapeutics
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CNTX-3001 CNTX-3001 Single intrathecal injection of CNTX-3001 Placebo Placebo Single intrathecal injection of normal saline
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events From baseline to the end of treatment visit (Day 7) Number of participants with TEAEs, which includes laboratory test variables
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) 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 Time to Maximum Observed Plasma Concentration (Tmax) of CNTX-3001 Pre dose to up to 4 hours post dose
Trial Locations
- Locations (1)
Neurovations
🇺🇸Napa, California, United States
Neurovations🇺🇸Napa, California, United States