A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Time to Reach Maximum Observed Serum Concentration (Tmax)
研究概览
简要总结
The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent subjects with asthma.
详细描述
Interleukin-13 (IL-13) is a pleiotropic cytokine that promotes inflammation, airways hyper-responsiveness (directly and through recruitment and activation of inflammatory cells), mucus hypersecretion, airway remodeling via fibrosis, increased immunoglobulin E (IgE) synthesis and mast cell activation.Tralokinumab (CAT-354) is a human immunoglobulin G4 (IgG4) anti-IL-13 monoclonal antibody that has been shown to potently and specifically neutralize IL-13 in preclinical models.This study will evaluate the PK profile of a single dose of tralokinumab administered subcutaneously at a dose of 300 mg in adolescent subjects with asthma to be compared with the PK data from completed studies in adults.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-17 years (inclusive)
- •Weight greater than (>) 30 kilogram (kg)
- •Asthma for a minimum of 6 months prior to Screening
- •Effective birth control for both male and female participants in line with protocol details.
排除标准
- •Previously taken tralokinumab (the study drug)
- •Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
- •Pregnant or breastfeeding women
- •Current smoker or cessation less than (<) 3 months prior to screening
- •Known immune deficiency excluding asymptomatic selective immunoglobulin A
- •History of cancer - Hepatitis B, C or human immunodeficiency virus (HIV) positive
- •Any disease which may cause complications whilst taking the study drug.
结局指标
主要结局
Time to Reach Maximum Observed Serum Concentration (Tmax)
时间窗: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Maximum Observed Serum Concentration (Cmax)
时间窗: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
时间窗: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
时间窗: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Terminal Phase Elimination Half Life (t1/2)
时间窗: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
次要结局
- Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)(Day 1 to Day 57)
- Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit(Day 1 and Day 57)