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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- 未提供
研究组 & 干预措施
Placebo
Single intrathecal injection of normal saline
干预措施: Placebo (Drug)
CNTX-3001
Single intrathecal injection of CNTX-3001
干预措施: CNTX-3001 (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: From baseline to the end of treatment visit (Day 7)
Number of participants with TEAEs, which includes laboratory test variables
次要结局
- 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)