A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 5
- 主要终点
- Incidence of Serious Adverse Events
研究概览
简要总结
Phase I study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI2338 in subjects with stable, mild to moderate chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 40 years at time of screening.
- •Females of non-childbearing potential defined as surgically sterile or at least 2 years postmenopausal.
- •Males, unless surgically sterile, must use 2 highly effective methods of birth control from screening through end of trial.
- •A diagnosis of mild to moderate COPD.
- •Cigarette smoking history of ≥10 pack years.
- •Ability to understand and comply with protocol requirements, instructions and restrictions.
- •COPD symptoms adequately controlled on a therapeutic regimen that has not changed in the 4 weeks prior to screening.
排除标准
- •Current diagnosis of any respiratory condition other than COPD.
- •Active or history of any disease or condition that would, in the opinion of the investigator and/or medical monitor, place the subject at an unacceptable risk to participate in this study.
- •History of or suspected history of alcohol misuse or recreational substance abuse.
- •Treatment with oral or IV corticosteroids within 8 weeks prior to screening.
- •Concurrent enrolment in another clinical study.
- •Receipt of any investigational drug therapy of use of any biologicals within 6 months prior to screening.
- •Known history of allergy or reaction to any component of the investigational product.
结局指标
主要结局
Incidence of Serious Adverse Events
时间窗: Days 1 - 92
Number of participants experiencing serious adverse events
Incidence of Clinically Significant Electrocardiogram Results
时间窗: Days 1 - 92
Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.
Incidence of Clinically Significant Vital Signs Results
时间窗: Days 1 - 92
Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.
Incidence of Clinically Significant Serum Chemistry Laboratory Results
时间窗: Days 1 - 92
Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.
Incidence of Adverse Events
时间窗: Days 1 - 92
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Incidence of Clinically Significant Hematology Laboratory Results
时间窗: Days 1 - 92
Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.
次要结局
- Area Under the Serum Concentration-Time Curve From Time Zero to Infinity(Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92))
- Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point(Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92))
- Incidence of Anti-drug Antibodies (ADA) to MEDI2338(Days 1, 57, and 92)
- Observed Maximum Concentration (Cmax)(Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92))
- Apparent Terminal Elimination Phase Half-life (t1/2)(Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92))
- Clearance (CL)(Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92))