A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Pharmacokinetic parameters, Cmax
研究概览
简要总结
To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.
详细描述
This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 and 55 years of age, inclusive
- •Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
- •Must be HIV negative by HIV 1/0/2 testing
- •Must be Hepatitis B (HBV) surface antigen negative
- •Must be Hepatitis C (HCV) antibody negative
- •Females must have a negative serum pregnancy test
- •Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug
排除标准
- •Pregnant or lactating subjects
- •Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
- •Have poor venous access and are unable to donate blood
- •Have been vaccinated within 90 days of study dosing
- •Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
- •Have history of significant drug sensitivity or drug allergy.
研究组 & 干预措施
2
Pegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ
干预措施: Pegilodecakin (Biological)
1
Pegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ
干预措施: Pegilodecakin (Biological)
结局指标
主要结局
Pharmacokinetic parameters, Cmax
时间窗: 43 days
maximal plasma concentration (Cmax)
Pharmacokinetic parameters, AUC
时间窗: 43 days
area under the plasma concentration curve (AUC)
Pharmacokinetic parameters, CL/F
时间窗: 43 days
clearance (CL/F).
Pharmacokinetic parameters, Tmax
时间窗: 43 days
maximal concentration (Tmax)
次要结局
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(43 days)