A Phase 1, Open-Label, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ASLAN004 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Evaluation of product safety by assessing the incidence of treatment-emergent adverse events following single ascending dose administration in healthy volunteers at Day 1 until study completion
研究概览
简要总结
This is an open-label, two-part, single-center, first in human (FIH), single ascending dose (SAD) study to assess the effects of single doses of ASLAN004 when administered to healthy subjects. The objective of this study is to evaluate the safety, tolerability, and Pharmacokinetics (PK) of ASLAN004 in healthy subjects.
详细描述
The plan is to enroll between 38 to 50 subjects at 1 study center.
The study is divided into 2 parts:
Part A is designed as a SAD study using intravenous (IV) administration of ASLAN004, as a single mg/kg IV dose and will consist of up to 6 IV cohorts.
Part B is designed as a parallel SAD study using subcutaneous (SC) administration of ASLAN004, as a single fixed milligram SC dose and will consist of up to 4 SC cohorts.
All cohorts will have sentinel dosing with the first subject of each cohort being spaced with adequate observation time of 24 to 48 hours before dosing the remaining subjects in the cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to sign informed consent form
- •Male and female subjects who are of legal age
- •Healthy, BMI 18.5 to 30 kg/m2
- •Normal or clinically acceptable clinical laboratory value and ECG results
排除标准
- •History of hypersensitivity reaction
- •Have food and/or topical allergies
- •Have recent history of conjunctivitis
- •Have active or history of psoriasis
结局指标
主要结局
Evaluation of product safety by assessing the incidence of treatment-emergent adverse events following single ascending dose administration in healthy volunteers at Day 1 until study completion
时间窗: 85 days
To evaluate the safety of the product by assessing its impact on the healthy volunteer following single dose administration through review of adverse event listings
次要结局
- PK parameters: Area under the curve (AUC) from time zero to the time of the last quantifiable concentration [AUC(0-last)](Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months)
- PK parameters: Dose-normalized Cmax (Cmax/dose)(Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months)
- PK parameters: Estimate of volume of distribution at steady state (Vss)(Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months)
- PK parameters: Subcutaneous bioavailability (F)(Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months)
- PK parameters: AUC (AUC(0-inf)/dose)(Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months)