A Phase 1 Double-blind, Single-dose, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects.
详细描述
This is a phase 1, single-dose, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects. Approximately 40 subjects will be entered to receive treatment across 4 fixed dose cohorts at 1 site. Investigational product will be delivered intravenously (IV). A total of 4 different dose levels of investigational product will be evaluated across the cohorts. Subjects will be followed for approximately 100 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 through 65 years at the time of screening
- •Weight ≥ 45 kg and ≤ 110 kg at screening
- •Healthy by medical history, physical examination, and baseline safety laboratory studies.
- •Systolic blood pressure (BP) < 140 mm Hg and diastolic BP < 90 mm Hg at screening
- •Electrocardiogram without clinically significant abnormalities at screening
- •Able to complete the follow-up period through Day 101 as required by the protocol
- •Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for at least 28 days prior to the first dose of investigational product and must agree to continue using such precautions through Day 101 of the study
排除标准
- •Acute illness, including fever > 99.5°F, on day prior to or day of planned dosing
- •Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine. and other nutritional supplements that have not been taken for at least 30 days prior to enrollment, are not exclusionary.
- •Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening
- •Receipt of immunoglobulin or blood products within 6 months prior to screening
- •Receipt of any vaccine within 14 days prior to investigational product dosing or planned receipt of any influenza vaccine within 100 days after investigational product dosing
- •Either history of active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine above the upper limit of normal or hemoglobin, white blood cell count, or platelet count below the lower limit of normal at screening
- •History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years
- •Pregnant or nursing mother
- •History of alcohol or drug abuse within the past 2 years tha OR positive Class A drug screen for amphetamines, barbiturates, opiates, or cocaine at screening.
研究组 & 干预措施
MEDI8852
MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) supplied as 50 mg/mL solution for infusion. MEDI8852 is being evaluated for treatment of patients hospitalized with influenza A.
干预措施: MEDI8852 (Drug)
Placebo
Solution containing no active ingredients
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852
时间窗: 28 days postdose
Clinical laboratory assessments (ie, serum chemistry, hematology, and urinalysis)
次要结局
- Pharmacokinetics of MEDI8852 in serum: systemic clearance (CL)(100 days postdose)
- Pharmacokinetics of MEDI8852 in serum: area under the concentration time curve from 0 to t (AUC 0-t) and from 0 to infinity (AUC 0-inf)(100 days postdose)
- Pharmacokinetics of MEDI8852 in serum: terminal-phase elimination (t½)(100 days postdose)
- Pharmacokinetics of MEDI8852 in serum: time to maximum serum concentration (Cmax)(100 days postdose)
- Incidence of anti-drug antibody to MEDI8852 in serum(100 days postdose)
- Pharmacokinetics of MEDI8852 in serum:volume at steady state (Vss)(100 days postdose)