A Randomized, Single-center, Double-blind, Placebo Controlled, First-in-human Trial With Single Ascending Intravenous Doses to Determine Safety, Tolerability and Pharmacokinetics of AON-D21 in Healthy Male Subjects
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
- Primary Safety Endpoint - Per Dosing Cohort number of participants with treatment-emergent adverse events as assessed by CTCAE.
研究概览
简要总结
The main purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamic parameters after single ascending intravenous doses of AON-D21 in healthy male subjects.
详细描述
This study will potentially include 5 sequential cohorts with 8 subjects per cohort, then 40 enrolled subjects in total. Within each dose group 6 subjects will be randomized to receive AON-D21 and 2 subjects will be randomly assigned to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple: Participant, Investigator, Outcomes Assessor and Care provider.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 to 55 years of age inclusive, at the time of signing the informed consent.
- •Body mass index (BMI) within the range 18 - 30 kg/m2 with a body weight between 50 kg and 120 kg.
- •Male subjects
- •Subject is healthy as determined by medical evaluation
- •Subject provided written informed consent
- •Subject is willing to comply with all requirements and restrictions according to the study protocol.
排除标准
- •Any concomitant disease, condition, or treatment that could interfere with the conduct of the study.
- •Any acquired or congenital immune deficiency.
- •Acute infection (including viral infections) in the preceding 6 weeks (8 weeks for respiratory infections).
- •Any concomitant disease, condition, or treatment that could interfere with the conduct of the study.
- •Any acquired or congenital immune deficiency.
- •Acute infection (including viral infections) in the preceding 6 weeks (8 weeks for respiratory infections).
- •Clinically relevant abnormality following the Investigator's review of the physical examination, vital signs, ECG and clinical study protocol-defined clinical laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the trial at screening and admission.
- •Evidence of COVID-19 signs or symptoms, exposure to infected person or confirmed COVID-19 infection within the last 2 weeks.
- •Use of any concomitant medication or prescribed or non-prescribed drugs within 2 weeks or 5 times the half-life, whichever is longer, prior to the first study treatment administration.
- •Administration of vaccine(s) within 2 weeks prior to screening or plans to receive such vaccines during the study.
- •Use of any investigational drug or participation in any clinical study within 30 days or 5 half-life times, whichever is longer, prior to dosing.
- •Positive drug or alcohol screen at screening and admission.
- •Any significant blood loss, donated one unit (450 mL) of blood or more, or donated plasma, or received a transfusion of any blood or blood products within 30 days prior to dosing.
- •Subjects who are unable to refrain from the consumption of Seville oranges, grapefruit or grapefruit juice and /or pomelos, exotic citrus fruits, grapefruit hybrids, starfruit or fruit juices from 72 hours prior to dosing on Day 1, until completion of the last pharmacokinetic (PK) blood sample time point.
- •Legal incapacity or limited legal capacity, or incarceration.
- •Inability to understand or communicate reliably with the Investigator.
研究组 & 干预措施
AON-D21
Single ascending doses by iv infusion.
干预措施: Intravenous AON-D21 (Drug)
Placebo
Placebo medication identical in appearance to active.
干预措施: Intravenous placebo (Drug)
结局指标
主要结局
Primary Safety Endpoint - Per Dosing Cohort number of participants with treatment-emergent adverse events as assessed by CTCAE.
时间窗: 14 days
Overall number of participants with treatment related treatment-emergent adverse events (TEAEs) as assessed by CTCAE per dosing cohort.
Primary Safety Endpoint - Overall number of participants with treatment-emergent adverse events (TEAEs) per dosing cohort as assessed by CTCAE.
时间窗: 14 days.
To determine the overall safety and tolerability of AON-D21 by analyzing number of participants with treatment-related adverse events as assessed by CTCAE. Nature, occurrence, and severity of treatment-emergent adverse events.
次要结局
- Pharmacokinetics of AON-D21.(14 days.)