A Phase 1, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenously Administered AVLX-144
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Safety and tolerability of AVLX-144
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo). Additionally, eight healthy elderly subjects (65-80 years of age, males and females), 6 on active drug and 2 on placebo, will be included in the study at one dose level, once the safety and tolerability of AVLX-144 has been documented in younger subjects.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects, body mass index (BMI) 18-28 kg/m2, body weight from 50 kg (females) or 60 kg (males) up to 100 kg, good general health.
排除标准
- •History or evidence of current clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, haematological, metabolic-endocrine, neurological, urogenital or psychiatric disorder. Febrile convulsions in childhood do not necessarily exclude a subject, but subjects with any type of generalized seizure in adulthood must be excluded. Personal or first-degree family history of congenital long QT syndrome or sudden death of a first-degree relative suspected to be due to long QT syndrome will also exclude the subject.
研究组 & 干预措施
Cohort 1
AVLX-144_dose1
干预措施: AVLX-144 (Drug)
Cohort 1
AVLX-144_dose1
干预措施: Placebo (Drug)
Cohort 4
AVLX-144_dose4
干预措施: AVLX-144 (Drug)
Cohort 4
AVLX-144_dose4
干预措施: Placebo (Drug)
Cohort 2
AVLX-144_dose2
干预措施: AVLX-144 (Drug)
Cohort 2
AVLX-144_dose2
干预措施: Placebo (Drug)
Cohort 3
AVLX-144_dose3
干预措施: AVLX-144 (Drug)
Cohort 3
AVLX-144_dose3
干预措施: Placebo (Drug)
Cohort 5
AVLX-144_dose5
干预措施: AVLX-144 (Drug)
Cohort 5
AVLX-144_dose5
干预措施: Placebo (Drug)
Cohort 6
AVLX-144_elderly
干预措施: AVLX-144 (Drug)
Cohort 6
AVLX-144_elderly
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of AVLX-144
时间窗: From randomisation to end of study participation
Safety and tolerability will be assessed by recording adverse events (AEs), by performing physical examinations and safety laboratory assessments (blood and urine), and by recording vital signs and electrocardiograms (ECGs).
次要结局
- Pharmacokinetics parameter(24 hrs)
- Pharmacokinetics parameter AUC(From start to end of assessment)
- Pharmacokinetics parameter elimination(From start to end of assessment)