NCT03542435已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023 When Administered Orally to Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treatment related adverse events
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female, 18 55 years of age, inclusive, at screening.
- •Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study.
- •BMI ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
- •Medically healthy with no clinically significant screening results.
- •For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using acceptable birth control methods:
- •Female of non childbearing potential: must have undergone sterilization procedures, at least 6 months prior to the first dose
- •Non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug/placebo.
- •Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
排除标准
- •Subject is mentally or legally incapacitated
- •History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- •History or presence of alcoholism or drug abuse within the past 2 years
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- •Females with a positive pregnancy test or is lactating.
- •Positive urine cotinine at screening.
- •Positive urine drug or alcohol results at screening
- •Any significant finding on the Columbia Suicidal Severity Rating Scale (C-SSRS)
- •Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- •Unable to refrain from or anticipates the use of any drug (e.g. prescription, recreational, etc.)
- •Donation of blood or significant blood loss within 56 days prior to the first dose.
- •Plasma donation within 7 days prior to the first dose.
- •Participation in another clinical study within 30 days prior to the first dose.
研究组 & 干预措施
SXC-2023
Experimental
Dose Escalation
干预措施: SXC-2023 (Drug)
Placebo
Placebo Comparator
Dose Escalation
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment related adverse events
时间窗: 18 days
Treatment related adverse events as a measure of safety and tolerability of SXC-2023 following multiple ascending doses
次要结局
- Pharmacokinetic Assessments: AUC(Up to 96 hr post dose)
- Pharmacokinetic Assessments: Cmax(Up to 96 hr post dose)
- Pharmacokinetic Assessments: Tmax(Up to 96 hr post dose)
研究者
研究点 (1)
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