A Single-Dose Study in Healthy Participants to Characterize Ramucirumab Pharmacokinetics and Investigate Injection Site Reactions Following an Intravenous Infusion or Subcutaneous Administration of Ramucirumab
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab
研究概览
简要总结
This study evaluates a new formulation of ramucirumab, a drug approved for several types of cancer.
In this study of healthy participants, a small amount of ramucirumab will be given by injection either into a vein or just under the skin. Study doctors will measure the amount of ramucirumab in the bloodstream.
Side effects and tolerability will be documented. The study will last for about 16 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
- •Have a body weight greater than or equal to (≥)70 kilograms (kg) and body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m ²), inclusive
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
排除标准
- •Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- •Have previously participated or withdrawn from this study
- •Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- •Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
研究组 & 干预措施
Placebo - Intravenous (IV)
Participants received single dose of placebo administered IV.
干预措施: Placebo - IV (Drug)
350 mg Ramucirumab IV
Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion.
干预措施: Ramucirumab - IV (Drug)
Placebo - Subcutaneous (SC)
Participants received single dose of placebo administered SC.
干预措施: Placebo - SC (Drug)
350 mg Ramucirumab SC (1x2 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
干预措施: Ramucirumab - SC (Drug)
350 mg Ramucirumab SC (2x2 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
干预措施: Ramucirumab - SC (Drug)
350 mg Ramucirumab SC (2x1 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
干预措施: Ramucirumab - SC (Drug)
700 mg Ramucirumab SC (2x2 mL)
Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
干预措施: Ramucirumab - SC (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab
时间窗: 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose
PK: AUC\[0-∞\] of Ramucirumab.
PK: Maximum Concentration (Cmax) of Ramucirumab
时间窗: 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose
PK: Cmax of Ramucirumab
Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug
时间窗: Day 1 Predose through Day 90
Number of participants showing ISRs when the drug was administered subcutaneously were reported.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 90
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
未报告次要终点