NCT07520292招募中1 期
The Effects of NTX-2001, a Novel TAAR1 Partial Agonist, on Alcohol Consumption in Adults With Alcohol Use Disorder: A Phase 1b, Randomized, Placebo-Controlled, Proof-of-Concept Study
Newleos Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年3月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of drinks consumed during the alcohol drinking paradigm (ADP).
研究概览
简要总结
The primary goal of this Phase 1b clinical trial is to evaluate the effects of a novel TAAR1 receptor partial agonist (NTX-2001) in adults with Alcohol Use Disorder (AUD). The main questions this trial aims to answer are:
- Does NTX-2001 affect alcohol consumption in adults with AUD?
- Is NTX-2001 safe and well tolerated in adults with AUD?
Researchers will compare the effects of NTX-2001 with matching placebo (look-alike capsule that contains no drug).
Participants will:
- Take NTX-2001 or matching placebo every day for 2 weeks
- Visit the clinic 4 times over the course of 10 weeks
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has provided written informed consent for the study and is willing to comply with all requirements of the protocol
- •English speaker
- •Male or female, ≥21 and ≤60 years of age.
- •Has a body mass index (BMI) 18 to 35 kg/m2 inclusive.
- •Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI).
- •If participant is of childbearing potential, must commit to practicing highly effective methods of birth control during the study and at least 14 days after the last dose.
排除标准
- •Currently seeking alcohol treatment or have been in alcohol treatment within the past 6 months
- •Reports disliking spirits (hard liquor)
- •Current diagnosis of substance use disorder, except for tobacco use disorder or mild cannabis use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)
- •Past or current diagnosis of schizophrenia spectrum or other psychotic disorder as defined by the DSM-5
- •Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening
- •Is at risk for suicidal ideation as per C-SSRS
- •Has moderate or severe hepatic impairment
- •Has moderate or severe renal impairment
- •Women who are pregnant or women who are currently breastfeeding unless they plan to stop breastfeeding for the duration of the study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
NTX-2001
Experimental
干预措施: NTX-2001 (Drug)
结局指标
主要结局
Number of drinks consumed during the alcohol drinking paradigm (ADP).
时间窗: Day 0 to Day 14
次要结局
- Incidence and severity of treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory throughout the study.(Day 0 to Day 21)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A study to evaluate SAR441566 efficacy and safety in adults with rheumatoid arthritisRheumatoid arthritis2023-503910-60-00Sanofi-Aventis Recherche & Developpement194
招募中
2 期
Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination with Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants with High-Risk Non-Muscle Invasive Bladder Cancer Unresponsive to Intravesical Bacillus Calmette-Guérin who are Ineligible for or Elected Not to Undergo Radical Cystectomy2023-506146-23-00Janssen - Cilag International130
尚未招募
2 期
Efficacy and Safety of TC011 in Relapsed or Refractory Follicular LymphomaNCT07360288TICAROS Co., Ltd.40
招募中
1 期
An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)NCT07392255Complement Therapeutics75
招募中
2 期
Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed/Refractory Primary or Secondary Central Nervous System LymphomaNCT07416890Zhejiang Cancer Hospital24