Study of Safety and PK of AZD0543 in Healthy Adults
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of AZD0543 in Healthy Adults
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：AstraZeneca Clinical Study Information Center
- 电话号码：1-877-240-9479
- 邮箱：information.center@astrazeneca.com
学习地点
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California
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Los Alamitos、California、美国、90720
- 招聘中
- Research Site
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Florida
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South Miami、Florida、美国、33143
- 招聘中
- Research Site
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Cohort 1: Low Dose AZD0543
Participants will receive a single AZD0543 dose. |
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1. |
|
安慰剂比较：Cohort 1: Placebo
Participants will receive a single dose of placebo. |
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1. |
|
实验性的：Cohort 2: Medium Dose AZD0543
Participants will receive a single AZD0543 dose. |
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1. |
|
安慰剂比较：Cohort 2: Placebo
Participants will receive a single dose of placebo. |
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1. |
|
实验性的：Cohort 3: High Dose AZD0543
Participants will receive a single AZD0543 dose. |
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1. |
|
安慰剂比较：Cohort 3: Placebo
Participants will receive a single dose of placebo. |
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Immediate AEs within 1 hour of IMP administration
大体时间：Within 1 hour of IMP administration
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To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Within 1 hour of IMP administration
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Injection/infusion-related reactions
大体时间：Within 24 hours of IMP administration
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To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Within 24 hours of IMP administration
|
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Injection/infusion site reactions
大体时间：Through Day 8 post-IMP administration
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To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Through Day 8 post-IMP administration
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AEs
大体时间：Through Day 91 post-IMP administration
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To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Through Day 91 post-IMP administration
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SAEs, MAAEs, and AESIs
大体时间：Throughout the study post-IMP administration
|
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Throughout the study post-IMP administration
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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AZD0543 serum concentrations over time
大体时间：Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
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AZD0543 Cmax
大体时间：Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
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AZD0543 Tmax
大体时间：Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
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AZD0543 t½λz
大体时间：Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
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AZD0543 AUClast
大体时间：Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
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AZD0543 AUCinf
大体时间：Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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AZD0543 CL
大体时间：Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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AZD0543 Vss
大体时间：Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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AZD0543 Vz
大体时间：Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
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To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
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Incidence of ADA; magnitude of ADA response
大体时间：Study Day 1 baseline; Study Day 8, 31, 91, 151, 361
|
To assess anti-drug antibody (ADA) responses to AZD0543 in serum |
Study Day 1 baseline; Study Day 8, 31, 91, 151, 361
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- D9190C00002
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计划共享个人参与者数据 (IPD)？
IPD 计划说明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共享时间框架
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 共享访问标准
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD 共享支持信息类型
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