A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Tralokinumab When Delivered as a 2 mL Injection at Different Flow Rates to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
研究概览
简要总结
The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.
详细描述
This is a Phase 1, open-label, assessor-blind, parallel-group study to evaluate the PK and tolerability of a single subcutaneous dose of 300 milligram (mg) tralokinumab when delivered as a 2 milliliters (mL) injection at different flow rates to healthy adult volunteers.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females ages 19-65 years
- •Body mass index of 19.0-30.0 kilogram per meter square (kg/m^2)
- •No clinically significant abnormality
- •Vital signs, electrocardiogram (ECG), and laboratory parameters within normal range
- •Negative alcohol and drug screens
- •Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception
- •Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective contraception.
排除标准
- •Concurrent enrollment in another clinical study where the subject is receiving an investigational product
- •Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer
- •Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
- •Current use of regular pain-modifying, anti-depressant, anxiolytic, or hypnotic medication
- •History of thrombocytopenia or bleeding disorder or use of anticoagulants
- •History of any immunodeficiency disorder or use of immunosuppressive medication.
- •History of a clinically significant infection
- •History of cancer
- •Positive Hepatitis B or C
- •Positive HIV
结局指标
主要结局
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
时间窗: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero to infinite time, obtained from AUC (0 - t) plus AUC (t - infinity). Units are day\*micrograms per millilitres = day\*mcg/mL.
Time to Maximum Concentration (Tmax)
时间窗: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Tmax is defined as actual sampling time to reach maximum observed tralokinumab concentration.
Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
时间窗: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
AUC \[0-t\] is defined as area under the serum concentration-time curve from zero to last observed tralokinumab concentration.
Maximum Observed Serum Concentration (Cmax)
时间窗: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
The Cmax is the maximum observed serum concentration of tralokinumab.
Apparent Terminal-Phase Volume of Distribution (Vz/F)
时间窗: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Terminal Elimination Half-life (t1/2)
时间窗: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Terminal elimination half-life is the time measured for the serum concentration to decrease by one half. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Apparent Systemic Clearance (CL/F) After Subcutaneous Dose
时间窗: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability).
次要结局
- Number of Participants Reporting Local Injection-Site Reactions(0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injection)
- Local Injection-Site Pain and Injection-Site Pruritus(During the injection until 72 hours post-injection for injection site-pain and immediately after administration of injection until 72 hours for injection-site pruritus)
- Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)(From start of study drug administration up to Day 57)
- Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination(Day 1 to Day 57)
- Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters(Day 1 to Day 57)
- Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit(Pre-dose on Day 1 and Day 57)
- Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs(Day 1 to Day 57)