A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Dose, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ALXN1101 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single dose of ALXN1101 in healthy adult subjects
研究概览
简要总结
Phase 1 single dose study of ALXN1101 in healthy volunteers.
详细描述
This is a first-in-human (FIH), randomized, blinded, placebo-controlled, single-dose, sequential-cohort, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of ALXN1101 in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects ≥ 18 and ≤ 60 years of age and weight ≥ 55 kg and ≤ 100 kg
- •Willing and able to give written informed consent
- •Female subjects of child bearing potential must have a negative serum pregnancy test or must be practicing an approved contraceptive regimen for the duration of the study
- •Male subjects must be practicing an acceptable barrier method of contraception
排除标准
- •Pregnant or nursing female subjects
- •QTcF > 450 msec for males and > 470 msec for females, or a family history of Long QT Syndrome.
- •CrCl < 80 mL/min
- •CBC in acceptable range; SGOT or SGPT above the ULN
- •HIV, Hepatitis B or Hepatitis C virus infection
- •Other active systemic infection or malignancy
- •Investigational drug study within 60 days
- •Major surgery within the prior 90 days
- •History of illicit drug use or chronic alcohol dependence within 2 years prior to this study
- •Positive urine drug toxicology screen or serum alcohol test
- •Alcohol consumption within 48 hours prior to study drug administration
- •Recently donated or lost ≥ 499 mL of blood
- •Recent hormone replacement therapy or use of prescription medications
研究组 & 干预措施
ALXN1101
Four cohorts planned. Within each cohort, healthy volunteers are randomized to ALXN1101 IV single dose or placebo IV single dose. Each subsequent cohort is testing an increased dose of ALXN1101 IV or placebo IV.
干预措施: ALXN1101 (Drug)
Placebo
Four cohorts planned. Within each cohort, healthy volunteers are randomized to ALXN1101 IV single dose or placebo IV single dose. Each subsequent cohort is testing an increased dose of ALXN1101 IV or placebo IV.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of single dose of ALXN1101 in healthy adult subjects
时间窗: following the Day 30 visit for the last study subject
Physical examination, vital signs, ECGs, laboratory evaluations, and Adverse Events.
次要结局
- PK parameters of ALXN1101(following the Day 5 visit for the last study subject)