NCT04111666已完成1 期
A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Alector Inc.
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- Evaluation of safety and tolerability of AL101 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)
研究概览
简要总结
A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics
详细描述
This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK, PD and Bioavailability of intravenously and sub-cutaneously administered AL101 in Healthy Volunteers.
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
- Quadruple (Participant, Care Provider, 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
- •BMI 18.0-35.0 kg/m2
- •45-120 kg, inclusive
- •At screening, females must be non-pregnant and non-lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal (amenorrhoea duration of 12 consecutive months); nonpregnancy will be confirmed for all females by a pregnancy test conducted at screening, (each) admission, and at follow-up.
- •Female participants of child-bearing potential must agree to use adequate contraception from screening until 90 days after the follow-up visit.
- •In good physical health on the basis of no clinically significant findings from medical history, physical examination (PE), laboratory tests, 12 lead ECG, and vital signs, as judged by the Investigator.
- •Willingness and able to comply with the study protocol, in the investigator's judgement.
排除标准
- •Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- •Positive drug or alcohol at screening and prior to first dose
- •History of alcohol abuse or substance abuse
结局指标
主要结局
Evaluation of safety and tolerability of AL101 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)
时间窗: either 57, 113, or 141 days, depending on the cohort
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
次要结局
- Pharmacokinetics (PK) of AL101(either 57, 113, or 141 days, depending on the cohort)
- Area under the curve concentration (AUC) for AL101(either 57, 113, or 141 days, depending on the cohort)
- Maximum plasma concentration (Cmax) for AL101(either 57, 113, or 141 days, depending on the cohort)
研究者
研究点 (3)
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