An Open Label, Randomized, Single Dose, 2-Way Crossover Study to Evaluate the Pharmacokinetics of Pre-filled Syringe Versus Vial 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 (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
研究概览
简要总结
The purpose of this study is to assess how fast pegilodecakin gets into the blood stream and how long it takes the body to remove it, when given as a solution formulation via a prefilled syringe (PFS) versus from a vial drawn into a conventional syringe. Information about side effects will be collected. The study is open to healthy participants. Total participant duration in trial is approximately 42 days.
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
- •Must have a body mass index (BMI) between 19.0 and 32.0 kilograms per meter squared (kg/m²) at study screening
- •Must be Human Immunodeficiency Virus (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
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
- •Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
- •Have smoked or used tobacco/nicotine products within 90 days prior to the study dosing
- •Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
- •Have been vaccinated within 90 days of study dosing
研究组 & 干预措施
Pegilodecakin Vial
Participants received Pegilodecakin subcutaneous (SQ) doses of 0.8 milligrams (mg) at 4 milligrams per milliliter (mg/mL) administered as 0.2 mL injections from a vial drawn into a conventional syringe
干预措施: Pegilodecakin (Biological)
Pegilodecakin Pre-filled syringe (PFS)
Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a pre-filled syringe.
干预措施: Pegilodecakin (Biological)
结局指标
主要结局
Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
时间窗: Predose through approximately 14 days postdose
Cmax of Pegilodecakin
PK: Time of Maximum Concentration (Tmax)
时间窗: Predose through approximately 14 days postdose
Tmax of Pegilodecakin
PK: Area Under the Serum Concentration Versus Time Curve (AUC)
时间窗: Predose through approximately 14 days postdose
AUC of Pegilodecakin
Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
时间窗: Period 1: Days 1 to 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 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose)
Pharmacokinetic (PK): maximum drug concentration (Cmax) of Pegilodecakin.
PK: Time of Maximum Concentration (Tmax) of Pegilodecakin
时间窗: Period 1: Days 1 to 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 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose)
Time of maximum serum concentration (Tmax) of Pegilodecakin.
PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC[0-inf] of Pegilodecakin
时间窗: Period 1: Days 1 to 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 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose)
PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC\[0-inf\] of Pegilodecakin.
次要结局
未报告次要终点