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A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults

2026年10月5日 更新者:AstraZeneca

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

地位

主动,不招人

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

介入性

注册 (实际的)

18

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Sumida-ku、日本、130-0004
        • Research Site

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

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:

  • Known hypersensitivity to any component of the study intervention.

  • Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.

  • Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.

  • AST or ALT above 1.5 × ULN at screening.

  • Estimated glomerular filtration rate < 90 mL/min/1.73 m2.

  • Hemoglobin or platelet count below the lower limit of normal at screening.

  • White blood cell counts outside normal reference ranges.

  • History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.

  • Any clinically significant abnormalities on 12-lead ECG at screening,

  • Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.

  • Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.

  • Any condition that has the potential to increase clearance of the study intervention.

  • Blood donation or collection as follows:

    1. 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
    2. 200 mL whole blood donation within 4 weeks prior to study drug administration.
    3. Apheresis donation within 2 weeks prior to study drug administration.
  • Absence of suitable veins for blood sampling and administration of study intervention.

  • Any other condition that would compromise the safety of the participants.

  • Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.

  • 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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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
Occurrence of Adverse Events (AEs)
大体时间:Day 1 to Day 181

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
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

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
Maximum observed serum (peak) drug concentration (Cmax)
大体时间:Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Time to reach peak or maximum observed concentration following drug administration (tmax)
大体时间:Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Terminal elimination half-life (t½λz)
大体时间:Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
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

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Area under the concentration-time curve from time 0 to infinity (AUCinf)
大体时间:Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Volume of distribution at steady state (Vss)
大体时间:Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Volume of distribution based on the terminal phase (Vz)
大体时间:Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Incidence of Anti-drug antibody (ADA)
大体时间:Day 1 to Day 361

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

在这里您可以找到参与这项研究的人员和组织。

赞助

合作者

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月29日

初级完成 (估计的)

2027年9月13日

研究完成 (估计的)

2027年9月13日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月5日

最后验证

2026年9月1日

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)?

是的

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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