A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose Intravenous Study to Evaluate the Safety and Pharmacokinetics of IXT-m200 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-related AEs Assessed by ECG
研究概览
简要总结
Approximately 9 participants will be enrolled in the study in a single cohort. Participants will be randomized to 3 g IXT-m200 or placebo at 7:2. Each will receive their dose as a 30-min intravenous infusion, then remain at the study site overnight to complete Day 1 and Day 2 assessments (e.g., electrocardiogram (ECG), laboratory assessments, blood draws, and vital signs). Following discharge on Day 2, participants will return to the clinic for follow-up pharmacokinetic (PK) and safety assessments on Day 8, then every 1-3 weeks thereafter until Day 127.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible participants will:
- •Be 18-65 years of age, inclusive, at the time of study consent;
- •Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent;
- •Be healthy, based on the pre-study medical evaluation (medical history and physical exam, vital signs, ECG, and clinical laboratory evaluations);
- •Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study;
- •Be of nonchildbearing potential or agree to use protocol-specified method(s) of birth control throughout study participation;
- •Agree to adhere to Lifestyle Considerations throughout study duration.
排除标准
- •Eligible participants will NOT:
- •Have a history of treatment with a monoclonal antibody in the past year;
- •Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other mAbs, any inactive ingredient of IXT-m200, or any other products required for the study procedures;
- •Have a history of alcohol and/or drug use disorder, as determined by DSM-5 criteria;
- •Have a history of stimulant use, including methamphetamine and amphetamine;
- •Be currently taking certain other drugs and medications, including: "designer drugs" (e.g., 3,4-methylenedioxyMETH (MDMA, Ecstasy, Adam, XTC) and its N-dimethyl metabolite methylenedioxyamphetamine (MDA), anti-orexigenic drugs (including over-the-counter medications for weight loss), or be chronic users of phenethylamine compounds (e.g., phenylpropanolamine, ephedrine, pseudoephedrine, amphetamine, phentermine, phenmetrazine, methylphenidate, diethylpropion, and propylhexedrine);
- •Have a positive drug screen for any psychoactive substances (legal or nonlegal) on Day 1 prior to dosing;
- •Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications;
- •Have a history of allergic or environmental bronchial asthma within the past 3 years;
- •Have a clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal, cardiovascular, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous (eg psychiatric conditions), or hematologic systems, or recent clinically significant surgery;
- •Have a history of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions;
- •Have a planned or scheduled surgical procedure during the study;
- •Have recently donated blood or plasma (within 30 days of study drug dose);
- •Have a current diagnosis of anorexia nervosa or bulimia disorder;
- •Be currently participating or has participated within the last 30 days prior to the start of this study in a drug, device, or other interventional research study;
- •Be pregnant or lactating;
- •In the Investigator's or Sponsor's (or designee) opinion, be inappropriate for the study.
研究组 & 干预措施
IXT-m200
3 g of IXT-m200 given once by 30-min intravenous infusion
干预措施: IXT-m200 (Drug)
Placebo
Normal saline
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With Treatment-related AEs Assessed by ECG
时间窗: 30 min post-dose completion
Electrocardiogram
Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations
时间窗: 127 days
Physical examinations
Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing
时间窗: 64 days
Clinical laboratory testing
Number of Participants With Treatment-related AEs Assessed by Vital Signs
时间窗: 127 days
Blood pressure, heart rate, and temperature
次要结局
- Time Course of IXT-m200 Concentrations(127 days)