NCT04392830已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study, to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD-MAD) of ALZ002 DS in Healthy Volunteers
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
- 72
- 试验地点
- 1
- 主要终点
- Incidence of SAEs and treatment-related adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single-ascending and multiple-ascending doses of ALZ002 DS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 male and/or non-childbearing potential female subjects, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age at screening.
- •Body mass index > 18.5 and < 30.0 kg/m2, and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening visit.
- •Capable of consent.
排除标准
- •Any clinically significant abnormality or abnormal laboratory test results
- •Positive urine drug screen, alcohol breath test, or urine cotinine test
- •History of significant allergic reactions to any drug.
- •Participation in a clinical research study involving the administration of an investigational or marketed drug or device
- •History of clinically significant opportunistic infection
- •Presence of fever (body temperature > 38°C)
研究组 & 干预措施
ALZ002 DS
Experimental
SAD: 6 cohorts of subjects are planned to be orally dosed, ranging from 15 mg - 800 mg.
MAD: 3 cohorts of subjects are planned to be orally dosed once or twice daily for 7 consecutive days, ranging from 300 mg - 600 mg.
干预措施: ALZ002 DS (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of SAEs and treatment-related adverse events
时间窗: Baseline through Study Completion (up to Day 14)
Incidence of SAEs and treatment-related severe AEs
次要结局
- Area Under the Curve (AUC) will be assessed(predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose)
- Maximum Plasma Concentration (Cmax) will be assessed(predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose)
研究者
研究点 (1)
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