NCT05891366已完成1 期
Safety, Pharmacokinetics, and Pharmacodynamics of a Single, Ascending Dose of WAL0921 in Healthy Subjects
Walden Biosciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of WAL0921 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, 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
- •Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing
- •Healthy individuals without known current or chronic medical conditions in the opinion of the Investigator
- •Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2
排除标准
- •Clinically significant findings in physical examination, vital signs (blood pressure, heart rate, and body temperature), ECG, and safety laboratory parameters at screening in the opinion of the Investigator
- •Renal function calculated by the CKD-EPI (2021) equation with eGFR <90 mL/min/1.73 m2 at the time of screening
- •Abnormal levels of proteinuria detected on Urine Protein-Creatinine Ratio (UPCR) test >0.30 g/g
- •Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems
研究组 & 干预措施
WAL0921
Experimental
Single intravenous infusion of investigational drug WAL0921
干预措施: WAL0921 (Drug)
Placebo
Placebo Comparator
Single intravenous infusion of normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: Day 1 to Day 64
次要结局
- Half-life(Day 1 to Day 64)
- Cmax(Day 1 to Day 64)
- Number of participants with clinically significant changes in chemistry lab values(Day 64)
- AUC(Day 1 to Day 64)
- Number of participants with clinically significant changes in hematology lab values(Day 64)
研究者
研究点 (1)
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