A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants
The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.
研究概览
详细说明
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and PK of AZD7760, a mAb combination of suvratoxumab (labeled as MEDI4893) and AZD7745, in healthy Japanese adults. Two dosages of AZD7760 each administered as a single IV dose, will be assessed.
Study details include:
- A Screening Period of up to 28 days.
- A Dosing Period of 3 days, in which a single IV infusion will be given on Day 1.
- A Follow-up Period of 12 months from the time of administration of the study intervention.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Sumida-ku、日本、130-0004
- 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
Inclusion Criteria:
- Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg/m2 (inclusive) at screening.
- Healthy Japanese participants with no clinically significant concomitant diseases or medications.
Exclusion Criteria:
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Known hypersensitivity to any component of the study intervention.
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Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.
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Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
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AST or ALT above 1.5 × ULN at screening.
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Estimated glomerular filtration rate < 90 mL/min/1.73 m2.
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Hemoglobin or platelet count below the lower limit of normal at screening.
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White blood cell counts outside normal reference ranges.
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History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.
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Any clinically significant abnormalities on 12-lead ECG at screening,
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Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.
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Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.
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Any condition that has the potential to increase clearance of the study intervention.
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Blood donation or collection as follows:
- 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
- 200 mL whole blood donation within 4 weeks prior to study drug administration.
- Apheresis donation within 2 weeks prior to study drug administration.
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Absence of suitable veins for blood sampling and administration of study intervention.
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Any other condition that would compromise the safety of the participants.
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Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.
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Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Cohort 1 (AZD7760 Dose A)
Participants receive an IV infusion of AZD7760 Dose A on Day 1. |
Participants will receive AZD7760 via IV infusion. |
|
实验性的:Cohort 2 (AZD7760 Dose B)
Participants receive an IV infusion of AZD7760 Dose B on Day 1. |
Participants will receive AZD7760 via IV infusion. |
|
安慰剂比较:Pooled Placebo
Participants receive an IV infusion of matching placebo on Day 1. |
Participants will receive matching placebo via IV infusion. |
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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Occurrence of Adverse Events (AEs)
大体时间:Day 1 to Day 181
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To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants. |
Day 1 to Day 181
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Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
大体时间:Day 1 to Day 361
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To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants. |
Day 1 to Day 361
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maximum observed serum (peak) drug concentration (Cmax)
大体时间:Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Time to reach peak or maximum observed concentration following drug administration (tmax)
大体时间:Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Terminal elimination half-life (t½λz)
大体时间:Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
|
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Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
大体时间:Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
|
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Area under the concentration-time curve from time 0 to infinity (AUCinf)
大体时间:Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Volume of distribution at steady state (Vss)
大体时间:Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Volume of distribution based on the terminal phase (Vz)
大体时间:Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
|
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Incidence of Anti-drug antibody (ADA)
大体时间:Day 1 to Day 361
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To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants |
Day 1 to Day 361
|
合作者和调查者
赞助
合作者
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
- D7480C00003
计划个人参与者数据 (IPD)
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 is accepting requests for IPD, but this does not mean all requests will be approved.
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 refer 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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