A First in Human, Double-Blind, Placebo-Controlled, Randomized Evaluation of Single Ascending Doses of ATI-1013, a Human Monoclonal Antibody to Nicotine in Healthy Smokers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of all adverse events (AEs)
研究概览
简要总结
This study is a first-in-human clinical trial of drug ATI-1013, in healthy adult cigarette smokers. The main questions it aims to answer are to learn about the safety of drug ATI-1013, how long drug ATI-1013 remains within the body, does drug ATI-1013 trigger an immune response, and the effects of drug ATI-1013 on nicotine levels within the body.
The clinical trial will compare drug ATI-1013 to a placebo (a look-alike substance that contains no drug) to see if drug ATI-1013 has comparable safety.
Participants will have a Screening visit (Day -28 to -3) and will be admitted on Day -2. Each participant will receive one intravenous (IV) infusion of ATI-1013 or placebo (Day 1). Participants will remain in-clinic for at least 48 hours post-dose and return for follow-up visits on Days 7, 21, 42, 56, and 84, with telephone check-ins on Days 5, 14, 28, and 70. Participants will keep a diary of their cigarette use and smoking behaviors.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 23 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ATI-1013 (0.2 g)
Single-ascending-dose Cohort 1. Participants receive a single intravenous (IV) infusion of ATI-1013 0.2 g on Day 1. Randomization within the cohort is 4:1 (ATI-1013:placebo).
干预措施: ATI-1013 (0.2 g) (Biological)
ATI-1013 (0.2 g)
Single-ascending-dose Cohort 1. Participants receive a single intravenous (IV) infusion of ATI-1013 0.2 g on Day 1. Randomization within the cohort is 4:1 (ATI-1013:placebo).
干预措施: Placebo (Other)
ATI-1013 (0.8 g)
Single-ascending-dose Cohort 2. Participants receive a single IV infusion of ATI-1013 0.8 g on Day 1. Randomization 4:1 (ATI-1013:placebo).
干预措施: ATI-1013 (0.8 g) (Biological)
ATI-1013 (0.8 g)
Single-ascending-dose Cohort 2. Participants receive a single IV infusion of ATI-1013 0.8 g on Day 1. Randomization 4:1 (ATI-1013:placebo).
干预措施: Placebo (Other)
ATI-1013 (3.2 g)
Single-ascending-dose Cohort 3. Participants receive a single IV infusion of ATI-1013 3.2 g on Day 1. Randomization 4:1 (ATI-1013:placebo).
干预措施: ATI-1013 (3.2 g) (Biological)
ATI-1013 (3.2 g)
Single-ascending-dose Cohort 3. Participants receive a single IV infusion of ATI-1013 3.2 g on Day 1. Randomization 4:1 (ATI-1013:placebo).
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of all adverse events (AEs)
时间窗: Day 1 through Day 84
Incidence of all adverse events (AEs), including infusion-related reactions (IRRs) and injection site reactions.
Development of Anti-Drug Antibodies
时间窗: Baseline (Day -1) through Day 84
Presence of anti-ATI-1013 antibodies following a single intravenous infusion.
次要结局
- Pharmacokinetics of ATI-1013 Maximum Concentration (Cmax)(Day 1 through Day 84)
- Pharmacokinetics of ATI-1013 Time to Maximum Concentration (Tmax)(Day 1 through Day 84)
- Pharmacokinetics of ATI-1013 Area Under the Curve (AUC)(Day 1 through Day 84)
- Pharmacokinetics of ATI-1013 Half-life (t1/2)(Day 1 through Day 84)
- Physiologic Responses to Nicotine (Skin Temperature)(Day -1 and Day 2)
- Physiologic Responses to Nicotine (Heart Rate)(Day -1 and Day 2)
- Physiologic Responses to Nicotine (Plasma Epinephrine)(Day -1 and Day 2)
- Physiologic Responses to Nicotine (Blood Pressure)(Day -1 and Day 2)
- Withdrawal Symptoms Minnesota Tobacco Withdrawal Scale (MTWS)(Day -1 and Day 2)
- Subjective/Psychological Effects of Nicotine Drug Effect Questionnaire (DEQ)(Day -1 and Day 2)
- Subjective/Psychological Effects of Nicotine Modified Cigarette Evaluation Questionnaire (mCEQ)(Day -1 and Day 2)
- Total Nicotine Levels(Baseline through Day 84)
- Free Nicotine Levels(Baseline through Day 84)
- ATI-1013-Bound Nicotine Levels(Baseline through Day 84)