An Open Label, Randomized, Single Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetics of Different Dose Levels and Dose Formulations of AM0010 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Pharmacokinetic parameters, CL/F
研究概览
简要总结
To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
详细描述
An open label, randomized, single dose, 3-way crossover study to evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study dosing and for 30 days following the last dose of study drug.
- •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
B
Pegilodecakin: Dose level depending on weight will be 0.4 mg or 0.8 mg, dose formulation 4 mg/mL.
干预措施: Pegilodecakin (Biological)
C
Pegilodecakin: Dose level depending on weight will be 0.4 mg or 0.8 mg, dose formulation 2 mg/mL.
干预措施: Pegilodecakin (Biological)
A
Pegilodecakin: Dose level depending on weight will be 0.8 mg or 1.6 mg, dose formulation 4 mg/mL.
干预措施: Pegilodecakin (Biological)
结局指标
主要结局
Pharmacokinetic parameters, CL/F
时间窗: 43 days
clearance (CL/F).
Pharmacokinetic parameters, Cmax
时间窗: 43 days
maximal plasma concentration (Cmax)
Pharmacokinetic parameters, Tmax
时间窗: 43 days
maximal concentration (Tmax)
Pharmacokinetic parameters, AUC
时间窗: 43 days
area under the plasma concentration curve (AUC)
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
时间窗: Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8]
Maximal serum concentration (Cmax) of pegilodecakin is reported.
PK: Time of Maximum Concentration (Tmax) of Pegilodecakin
时间窗: Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8]
Time of maximum serum concentration (Tmax) of Pegilodecakin is reported.
PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin
时间窗: Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8]
AUC from time 0 to the time of the last quantifiable concentration \[AUC(0-tlast)\], AUC from time 0 to 72 hours \[AUC(0-72)\] and AUC from time 0 to infinity \[AUC(0-inf)\] of pegilodecakin is reported.
PK: Apparent Total Body Clearance of (CL/F) of Pegilodecakin
时间窗: Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8]
Apparent total body clearance ((CL/F) is the volume of serum from which the drug is completely removed in a given time period.
次要结局
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(43 days)