A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.
详细描述
This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the PK, safety and tolerability, and ADA of nirsevimab when administered as a single fixed IM dosage to healthy Chinese adult subjects. Enrolment is planned at a single study center in China. Approximately 24 subjects will be randomly assigned in a 3:1 ratio to receive nirsevimab (n = 18) or placebo (n = 6). All subjects will be followed for approximately 150 days after dosing to assess safety, PK, and ADA response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age 18 to 45 years
- •Weight ≥ 45 kg and ≤ 110 kg and Body Mass Index of 19 to 26 kg/m2
- •Healthy Chinese subjects (both male and female)
- •Normotensive
- •Normal electrocardiogram (ECG) within 28 days prior to Day 1
排除标准
- •Acute illness at study entry (pre-dose on Day 1)
- •Fever ≥99.5°F (37.5°C) on day of dosing
- •Any drug therapy within 14 days prior to Day 1 (except contraceptives).
- •Receipt of immunoglobulin or blood products within 6 months prior to study entry.
- •Receipt of any investigational drug therapy within 120 days prior to investigational product dosing or planned to receive any investigational drug therapy within 150 days after investigational product dosing.
- •Previous receipt of any marketed or investigational mAb.
- •Previous vaccination against RSV.
- •History of immunodeficiency or receipt of immunosuppressive medications during the prior year.
- •History of asthma.
- •History of autoimmune disorder.
- •Evidence of any systemic disease on physical examination.
- •Evidence of infection with hepatitis A, B, or C virus, syphilis, or human immunodeficiency virus.
- •Any clinically significant abnormal laboratory assessments at screening.
- •Pregnant or nursing mother.
- •Alcohol or drug abuse
研究组 & 干预措施
Placebo
Placebo single dose IM injection
干预措施: Placebo (Other)
Nirsevimab
Nirsevimab single dose IM injection
干预措施: nirsevimab (Biological)
结局指标
主要结局
Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab
时间窗: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Tmax for nirsevimab was directly calculated from the individual concentration-time curve.
Maximum Observed Serum Concentration (Cmax) for Nirsevimab
时间窗: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Cmax for nirsevimab was directly calculated from the individual concentration-time curve.
Serum Concentrations of Nirsevimab
时间窗: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose.
Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab.
Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab
时间窗: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab was calculated by linear up/log down trapezoidal summation.
次要结局
- Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab(Baseline (Day 1) and Days 31, 91 and 151)