A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY001-001 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Treatment emergent adverse events
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose, first in human safety, tolerability, and pharmacokinetic study of SPY001-001 in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy men and women
- •Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits
排除标准
- •Participation in more than one cohort
- •Evidence of clinically significant abnormality or disease
- •Known history of illicit drug use or drug abuse, harmful alcohol use or alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study drug
- •History of severe allergic reactions or hypersensitivity
- •Donation or loss of >1 unit of whole blood within 1 month prior to dosing
研究组 & 干预措施
SAD Cohorts 1-5 Experimental Arm
Participants will receive a single dose of SPY001-001 in a dose escalation format
干预措施: SPY001-001 (Drug)
SAD Cohorts 1-5 Placebo Arm
Participants will receive a single dose of placebo
干预措施: Placebo (Other)
SAD Cohorts 6-7 Experimental Arm
Participants of Japanese descent will receive a single dose of SPY001-001
干预措施: SPY001-001 (Drug)
SAD Cohorts 6-7 Placebo Arm
Participants of Japanese descent will receive a single dose of placebo
干预措施: Placebo (Other)
SAD Cohorts 8-9 Experimental Arm
Participants of Chinese descent will receive a single dose of SPY001-001
干预措施: SPY001-001 (Drug)
SAD Cohorts 8-9 Placebo Arm
Participants of Chinese descent will receive a single dose of placebo
干预措施: Placebo (Other)
结局指标
主要结局
Treatment emergent adverse events
时间窗: Up to 64 weeks
Incidence, severity, and causal relationship of TEAEs
次要结局
- Cmax(Up to 64 weeks)
- Tmax(Up to 64 weeks)
- t1/2(Up to 64 weeks)
- AUC(Up to 64 weeks)
- ADA(Up to 64 weeks)