A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Food Effect of SXC-2023 When Administered Orally to Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Subjects Experiencing TEAEs.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect 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 females (women of non child bearing potential), 18-55 years of age (inclusive).
- •Medically healthy with no clinically significant screening results.
- •Non-vasectomized male subjects must agree to use birth control or abstain from sexual intercourse during and until 90 days beyond the last dose of study drug/placebo.
- •Continuous non-smoker, at least 3 months prior to first dose and throughout the study.
- •Understands the study procedures in the informed consent form, 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, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
- •History or presence of alcoholism or drug abuse within the past 2 years
- •Female subject of childbearing potential.
- •Blood donation or significant blood loss within 56 days prior to first dose.
- •Plasma donation within 7 days prior to first dose.
- •Participation in another clinical trial within 30 days prior to first dose.
研究组 & 干预措施
SXC-2023, 50 mg
Single dose of 50 mg, given orally in capsule form.
干预措施: SXC-2023 (Drug)
SXC-2023, 100 mg
Single dose of 100 mg, given orally in capsule form.
干预措施: SXC-2023 (Drug)
SXC-2023, 200 mg
Single dose of 200mg, given orally in capsule form.
干预措施: SXC-2023 (Drug)
SXC-2023, 400 mg
Single dose of 400mg, given orally in capsule form.
干预措施: SXC-2023 (Drug)
SXC-2023, 800 mg
Single dose of 800mg, given orally in capsule form.
干预措施: SXC-2023 (Drug)
SXC-2023, 1600 mg
Single dose of 1600 mg, given orally in capsule form.
干预措施: SXC-2023 (Drug)
Placebo oral capsule
Placebo comparator, given once orally in matching capsule form.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Number of Subjects Experiencing TEAEs.
时间窗: 8 days
Treatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments.
次要结局
- Pharmacokinetic Assessments: Cmax(Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.)
- Pharmacokinetics Assessments: Tmax(Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.)
- Pharmacokinetic Assessments: AUC(Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.)
- Pharmacokinetic: Food Effect, AUC(Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.)
- Pharmacokinetic: Food Effect, CMax(Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.)