A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of AZD0543 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Immediate AEs within 1 hour of IMP administration
研究概览
简要总结
The purpose of this study is to assess the safety and PK of AZD0543 compared to placebo in healthy adults 18 to 55 years of age. AZD0543 or placebo will be administered as single IM or IV dose. The study duration will be approximately 12 months for each participant following administration of IMP.
详细描述
A phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of AZD0543 in healthy adults 18-55 years of age. 144 participants will be randomized to receive either one of 3 dose levels of AZD0543 or a placebo comparator of the same volume. AZD0543 or placebo will be administered as a single dose on Day 1 via intramuscular (IM) injection or intravenous (IV) infusion. Participants will be followed for approximately 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 55 years
- •Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range ≥ 18.0 kg/m2 to ≤ 30 kg/m2
排除标准
- •Hypersensitivity to IMP/components
- •Severe adverse reaction/hypersensitivity to other mAbs
- •Acute fever/illness/infection within 3 days of planned dosing
- •Clinically important illness/procedure/trauma within 4 weeks of IMP administration
- •Active infection with Hepatitis B/C
- •Clinically significant bleeding disorders
- •Known/suspected immune deficiency/suppression
- •Receipt of blood products/immunoglobulins or immunosuppressive therapies within 6 months prior to screening (immunosuppressive medications/therapies include glucocorticoids exceeding 2 weeks of prednisone (or equivalent) 20mg daily or every other day)
- •Malignancy within previous 5 years; except treated non-melanoma skin cancers and locally treated cervical cancer
- •Receipt of any licensed/investigational hMPV vaccine, other therapies and procedures as applicable; participation in other clinical studies
- •Screening Abnormalities: clinically significant ECG, positive drug panel, Hgb/platelets/WBC outside of reference; all SCr/AST/ALT > 1.5X ULN
- •Women who are pregnant, lactating, or of childbearing potential and not using a highly effective birth control method
研究组 & 干预措施
Cohort 1: Low Dose AZD0543
Participants will receive a single AZD0543 dose.
干预措施: AZD0543 (Biological)
Cohort 1: Placebo
Participants will receive a single dose of placebo.
干预措施: Placebo (Other)
Cohort 2: Medium Dose AZD0543
Participants will receive a single AZD0543 dose.
干预措施: AZD0543 (Biological)
Cohort 2: Placebo
Participants will receive a single dose of placebo.
干预措施: Placebo (Other)
Cohort 3: High Dose AZD0543
Participants will receive a single AZD0543 dose.
干预措施: AZD0543 (Biological)
Cohort 3: Placebo
Participants will receive a single dose of placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Immediate AEs within 1 hour of IMP administration
时间窗: Within 1 hour of IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Injection/infusion-related reactions
时间窗: Within 24 hours of IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Injection/infusion site reactions
时间窗: Through Day 8 post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
AEs
时间窗: Through Day 91 post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
SAEs, MAAEs, and AESIs
时间窗: Throughout the study post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
次要结局
- AZD0543 serum concentrations over time(Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361)
- AZD0543 Cmax(Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361)
- AZD0543 Tmax(Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361)
- AZD0543 t½λz(Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361)
- AZD0543 AUClast(Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361)
- AZD0543 AUCinf(Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361)
- AZD0543 CL(Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361)
- AZD0543 Vss(Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361)
- AZD0543 Vz(Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361)
- Incidence of ADA; magnitude of ADA response(Study Day 1 baseline; Study Day 8, 31, 91, 151, 361)