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
- Maximum Observed Serum Concentration (Cmax) 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
结局指标
主要结局
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.
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.
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)