A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ALXN1007 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Safety and tolerability of a single dose of ALXN1007.
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose of ALXN1007 in healthy volunteers.
详细描述
All subjects will be screened for eligibility after providing signed informed consent. Once a subject is determined to be eligible, the subject will be vaccinated with the quadrivalent meningococcal conjugate vaccine at least two weeks prior to dosing, if applicable. A total of 7 dose cohorts will be enrolled sequentially and randomized to receive ALXN1007 or placebo. Subjects will receive ALXN1007 or placebo at the clinic and be kept at the clinic for a total of 4 days for observation and completion of the required study tests.
The subjects will return for 8 additional clinic visits to complete the required study tests over the next 86 days. The total duration of the study is 90 days from the day of dosing with ALXN1007 or placebo.
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals 25 to 55 years of age with documented vaccination with MCV4.
排除标准
- •Abnormal renal or liver function.
- •History of meningococcal disease.
- •History of Guillain-Barre syndrome.
- •Known infection with HIV or Hepatitis B or C.
研究组 & 干预措施
Cohort 4
1.0 mg/kg ALXN1007
干预措施: ALXN1007 (Drug)
Cohort 4
1.0 mg/kg ALXN1007
干预措施: Placebo (Other)
Cohort 5
3.0 mg/kg ALXN1007
干预措施: ALXN1007 (Drug)
Cohort 5
3.0 mg/kg ALXN1007
干预措施: Placebo (Other)
Cohort 6
6.0 mg/kg ALXN1007
干预措施: ALXN1007 (Drug)
Cohort 6
6.0 mg/kg ALXN1007
干预措施: Placebo (Other)
Cohort 7
10.0 mg/kg ALXN1007
干预措施: ALXN1007 (Drug)
Cohort 7
10.0 mg/kg ALXN1007
干预措施: Placebo (Other)
Cohort 3
0.3 mg/kg ALXN1007
干预措施: Placebo (Other)
Cohort 1
0.06 mg/kg ALXN1007
干预措施: ALXN1007 (Drug)
Cohort 1
0.06 mg/kg ALXN1007
干预措施: Placebo (Other)
Cohort 2
0.1 mg/kg ALXN1007
干预措施: ALXN1007 (Drug)
Cohort 2
0.1 mg/kg ALXN1007
干预措施: Placebo (Other)
Cohort 3
0.3 mg/kg ALXN1007
干预措施: ALXN1007 (Drug)
结局指标
主要结局
Safety and tolerability of a single dose of ALXN1007.
时间窗: Up to 90 days
Safety and tolerability of a single dose of ALXN1007 assessed by physical exam, vital signs, ECG, immunogenicity, lab analysis and adverse events.
次要结局
- PD parameters of ALXN1007(Up to 90 days)
- PK parameters of ALXN1007(Up to 90 days)