A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of MEDI-557, a Humanized Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus (RSV), Administered to Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.
详细描述
A Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of MEDI-557 administered IV to healthy adult subjects (18-45yrs). A maximum of 42 subjects from 1 site will be enrolled in a 2:3:2 ratio (12 placebo, 18 MEDI-557 low-dose, 12 MEDI-557 high-dose) to allow for greater data collection in the low-dose group. Subjects are evaluated for safety from time of Informed Consent through Study Day 360 post dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-45 years
- •written informed consent obtained from subject prior to performing any protocol related procedures
- •healthy by medical history and physical exam
- •females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and through 1 year after administration of study drug
- •nonsterilized, sexually active males with female partner of child-bearing potential must use 2 effective methods of birth control from Day 1 through Day 361
- •weight </= 110kg with a body mass index of <32kg/m2
- •ability to complete a follow-up period of approximately 360 days
排除标准
- •inability to complete a follow-up period of 360 days
- •any condition in the opinion of investigator that would interfere with evaluation of IP or interpretation of subject safety or study results
- •concurrent enrollment in another clinical study
- •employees of the site or other individuals involved with the conduct of the study or immediate family members of such individuals
- •receipt of immunoglobulin or blood products within 60 days prior to randomziation
- •receipt of any investigational drug therapy within 6 months prior to IP dosing
- •clinically abnormal ECG at screening
- •blood donation in excess of 400mL, wihtin 6 months prior to randomization
- •previous receipt fo biologics
- •history of immunodeficiency
- •history of allergic disease or reactions likely to be exacerbated by any component of the IP
- •previous medical history or evidence of interurrent illness that may compromise the safety of the subject
- •positive lab test for Hep A, B, C or HIV
- •pregnancy or nursing mother
- •history of alcohol or drug abuse within past 2 years
- •positive urine Class A drug screen
- •acute illness within 7 days prior to randomization
- •fever >/= 99.5F witin 7 days prior to randomization
- •any drug therapy within 7 days prior to randomization
- •systolic BP >150mmHG and/or diastolic BP>90mmHg
- •receipt of vaccine within 14 days prior to randomization
- •abnormal study labs (hem/wbc/platelet/BUN - see protocol for specific information)
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
MEDI-557 low-dose
干预措施: MEDI-557 (Drug)
MEDI-557 high-dose
干预措施: MEDI-557 (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: from Day 1 (pre-dose) through 360 days post dose.
Clinical lab measurements - chemistry, hematology; Urinalysis
次要结局
- Pharmacokinetic Assessments - Serum(1st dose through 360 days post dose)
- Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash(1st dose through 360 days post dose)
- Pharmacokinetic Assessments - Nasal Wash(1st dose through 360 days post dose)
- anti-RSV antibody in Serum and Nasal Wash(1st dose through 360 days post dose)